2009 Product Recalls
1,443 recalls issued in 2009.
Showing 41–60 of 1,443 recalls
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile, Zimmer Inc., Warsaw, IN; REF 32-8105-027-04. The device is utilized for a total elbow arthroplasty surgical procedure.
The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.
Consignees were notified by "Urgent Device Correction" letter dated January 30, 2009 and provided revised surgical techniques for these extra-small implants. Direct questions about this recall to Zimmer, Inc. at 574-267-6131.
Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07. A reusable cutting instrument that is used in total knee arthroplasty surgery.
The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.
Distributors were notified by an "Urgent: Device Recall" letter dated March 13, 2009. The letter described the affected product, reason for recall, health risks and actions for distributors and user facilities. Customers were instructed to quarantine affected instruments and return them to the Zimmer Product Service Department. Distributors were also instructed to provide the name and address of hospitals where the instruments were used so that a copy of the recall letter can be forwarded to the user facilities. Direct questions about this recall to Zimmer, Inc. by calling 800-613-6131.
Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448.
Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.
Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians.
Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; Catalog Number: 6428-32-02. Orthopedic implant used in total hip arthroplasty.
The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.
Zimmer, Inc. issued "Urgent: Device Recall" notices dated May 29, 2009 informing Consignees of the affected devices. Users were instructed to locate and return affected product and complete and return an Inventory Return Certification form via fax to the firm at 1-547-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.
Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00.
Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.
Zimmer sent an Urgent Device Recall letter dated 6/5/09 to all consignees and instructed to locate and return the products.
Sunrise Medical Quickie Groove Power Wheelchair with Transit option The product is a powered wheelchair for human use.
Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash.
Initial phone contacts began on November 13, 2006. Letters were also mailed. The letter informed the customer of the problem and provided interim steps to take, until an transit upgrade kit is installed. Response cards will be tracked to measure response rate and assure receipt of notice. Contact Sunrise Medical at 1-800-456-8168 for assistance.
PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
Product may give Lp-PLA2 values at up to 22% lower than accurate values.
All customers received communication of product correction dated July 18. 2008, via Federal Express, which included a cover letter, technical bulletin, specimen handling best practices cards, and revised package inserts. E-mail communication was also sent to all but seven customers. Contact diaDexus Technical Support at 1-877-752-2837 for assistance.
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13. Shoulder replacement surgery.
Some of the devices may possess a taper which will not mate with the humeral head, as intended.
Zimmer distributors were notified by email on 9/19/09 to locate and return the products. Letter dated 9/29/09 were sent to the Zimmer salesforce and distributors with a letter to be given to each affected hospital account to inform them of the problem. Zimmer accounts were again asked to locate and return the devices. Hospital accounts were requested to consider the available facts when monitoring potentially affected patients.
ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitachi Medical Systems of America)
There is a potential for inaccurate, elevated SUVs (standardized uptake values). On follow-up scans, the elevated SUV could be misinterpreted, and inappropriately impact a patient's treatment plan.
Written notification was sent out beginning 03/28/2006 to end users to advise them of the problem. The notification also included specific work instructions to aid the end user until the patch is available and the upgrade could be performed by a service representative.
Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-01. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.
The c-clip located near the connection end may fracture or fall off during use in surgical procedures.
U.S. consignees were notified by "Urgent: Device Recall" letter issued via e-mail on December 19, 2008. The letter described the problem and instructed customers to immediately quarantine and return the recalled product along with the completed Inventory Return Certification form to the Zimmer, Inc. Distribution Center. Consignees were also instructed to fax a copy of the completed Inventory Return Certification Form at 1-574-371-8603. International consignees were also notified, but Zimmer, Inc. will gather the instruments from those customers. Direct questions about the recall to Zimmer, Inc. at 1-800-613-6131.
Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01. Reusable instrument that is used to apply the appropriate torque to the lock nut that is part of the Silhouette Spinal Fixation System.
Some of the torque wrenches apply less than the minimum torque to the screw locking cap when the torque indicators are aligned as described in the surgical technique.
The firm's sales force was notified by an Urgent: Device Recall letter dated 10/7/08, which instructed them to stop using the instrument and quarantine it immediately; physically count all affected product in their territory and record data on the Inventory Return Certification Form; fax a copy of the completed form to Zimmer Spine; and return the affected devices with the completed Inventory Return Certification Form. User accounts/implanting physicians were informed by an Urgent: Device Recall letter dated 12/10/08 and instructed to monitor their patients.
Holding Forceps for Trident Acetabular System; non Sterile; Catalog number 2105-0000; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430; Authorized representative in Europe: Stryker France, Cedex. France The Holding Forceps for Acetabular trial cups help facilitate the insertion / correction of the Acetabular trial inserts.
The tips of the forceps were larger than the positioning holes located on the trials and the implant liners.
Important Product Correction letters, dated January 24, 2007, were sent to all consignees on via Federal Express. The letter stated the problem and asked customers to examine their inventory and hospital locations to identify the affected product. All affected forceps product should be retrieved from hospitals and returned to their branch or agency warehouse for reconciliation. Customers are also to reconcile all affected product on the attached Product Accountability Form and fax a copy of that form to 201-831-6069 within 5 days of receipt of the letter. All affected forceps product is to be destroyed and discarded at their branch location. Questions should be directed to their Stryker Orthopaedics Customer Service rep at 1-866-OR-ASSIST.
diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as
Storage equipment failure at distributor site due to Hurricane Ike caused product to experience a temperature variation and go out of range. The integrity of the product could not be assured.
The firm and its distributor contacted the consignees via phone on 11/04/08. The firm informed them of the issue and inquired about the products' status. An Urgent: Device Recall letter was issued on 11/04/08 via FedEx. The letter requested that use of the kit be immediately discontinued and returned promptly. A phone call was made to follow up requesting return of the product.
HORIZON LED SIDE DESTINATION SIGN/LUMINATOR
A SHORT COULD OCCUR, POSSIBLY CAUSING SMOKE AND FIRE.
NOVA BUS WILL NOTIFY OWNERS AND LUMINATOR WILL REPAIR THE BUSES FREE OF CHARGE. PLEASE SEE LUMINATOR'S DEFECT REPORT 09E-054. THE SAFETY RECALL BEGAN ON FEBRUARY 26, 2010. OWNERS MAY CONTACT LUMINATOR AT 1-972-516-3033 OR NOVA BUS AT 1-450-472-6410.
REPLACE MIDDLE CLIP OF A-PILLAR COVER
IF THIS HAPPENS, A LOOSE TRIM PIECE COULD INJURE THE FRONT SEAT OCCUPANTS OF THE VEHICLE.
VOLKSWAGEN WILL INSPECT THE CLIP IN THE MIDDLE OF THE LEFT AND RIGHT A-PILLAR COVERS AND REPLACE IT FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 22, 2010. OWNERS MAY CONTACT AUDI AT 1-800-253-2834.
FUEL PUMP LEAK
IF THE CONDITION OCCURS VEHICLE OWNERS MAY NOTICE FUEL SMELL AND/OR FUEL LEAK WHICH, IN THE PRESENCE OF AN IGNITION SOURCE, COULD RESULT IN A FIRE.
DEALERS WILL INSPECT THE FUEL PUMP INSTALLED IN THE VEHICLE, AND IF NECESSARY REPLACE THE FUEL PUMP WITH A PART OF A MODIFIED DESIGN. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 15, 2010. OWNERS MAY CONTACT VOLVO AT 1-800-458-1552.
Dorel Infant Car Seat/Carriers Recalled for Fall Hazard
When used as an infant carrier, the child restraint handle to the seat can loosen and come off, posing a fall hazard to infants.
Consumers should not use the handle of the car seat/carrier until the repair kit has been installed. The product can continue to be used as a car seat when properly installed in the vehicle. Contact Dorel Juvenile Group to receive a free repair kit.
Vicks Dayquil Cold & Flu 24-Count Bonus Pack Liquicaps Recalled for Poisoning Hazard
The cold and flu medicine contains acetaminophen and is not in child-resistant packaging and lacks the statement, "This Package for Households Without Young Children," as required by the Poison Prevention Packaging Act. This medicine could cause serious health problems or death to a child if several of the capsules are swallowed.
Consumers should keep this product out of the reach of children. Consumers who purchased the product with the expectation that it would be in child-resistant packaging can contact Procter & Gamble for a full refund or a replacement coupon. Adult consumers can continue to use the product as directed.
ELECTRONIC CONTROL MODULE/POSSIBLE ENGINE FIRE
THIS CONDITION WILL PERMIT HOT EXHAUST GASES TO EXIT THE VEHICLE TAILPIPE, INCREASING THE RISK OF MELTING OR BURNING OF NEARBY SURFACES, OR A FIRE.
SUTPHEN CORPORATION IS WORKING WITH CUMMINS TO REPAIR THE ENGINES FREE OF CHARGE. PLEASE SEE CUMMINS' DEFECT REPORT 09E-046. OWNERS MAY CONTACT CUMMINS AT 1-800-DIESELS (1-800-343-7357).
HANDLE DETACHMENT
IF THIS OCCURS, THE RESTRAINT CAN FALL, POSSIBLY RESULTING IN INJURY TO THE CHILD.
DJG WILL PROVIDE OWNERS WITH A FREE REPAIR KIT. THE SAFETY RECALL BEGAN ON JANUARY 8, 2010. OWNERS MAY CONTACT DJG AT 1-866-762-3316.