2021 Product Recalls

Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.

Incorrect product is contained in the packaging.

The recalling firm issued a recall letter dated 03 Dec 2021 on 12/3/2021 via Fed Ex Priority Overnight. The letter explained the packages contain the incorrect screws, provides potential risks and the actions needed to be taken. The consignee is to immediately check their inventory to locate the packaged product and remove them from their point of use. The enclosed business reply form was to be returned via email to confirm receipt of the letter and document product segregation. After the firm receives the reply form, the consignee will be contacted to arrange for return and replacement. The consignee was given the choice of providing subdistribution contact details to the recalling firm so the recalling firm could inform them of the recall, or the consignee can notify their downstream customers of the recall.

3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.

Products do not meet stability criteria and may impact results.

Consignees are informed of this issue by Field Safety Notice FSN 03-2020 on 11/02/2020, also addressing the measures that should be taken by the consignees: If the products listed above were already used for measurements, consignees shall check with the attending physician(s) whether it is necessary to review the results of asparagine, homocystine and methionine. Consignees shall stop using the reconstituted products listed above that are stored more than 6 weeks at < -18 C for measurements of asparagine, homocystine and methionine. Consignees shall destroy the remaining stock of reconstituted calibrators and controls that are stored more than 6 weeks at < -18 C and were intended to be used in measurements of asparagine, homocystine and methionine according to their valid laboratory regulations. Chromsystems will replace stocks. Calibrators and controls will now have a reduced in-use stability (after reconstitution) for asparagine, homocystine and methionine of 6 weeks at < -18 C. For all other analytes, in-use stability is not changed. If consignees have forwarded any of the products listed above to another laboratory, consignees shall inform that laboratory of the content of this letter and forward a copy. Consignees shall document their measures on provided Response document (attachment Response) and return their response until 20.11.2020 to Chromsystems (contact details provided in the attachment Response). Consignees shall make sure that all users of the products mentioned above and other persons affected in their organization are informed about the FSN. If they have provided third parties with these products, they shall forward a copy of this information or inform the contact person of Chromsystems.

FSIS Issues Public Health Alert for Frozen Wonton Soup Products Due to Undeclared Allergens and Misbranding

Misbranding, Unreported Allergens

FSIS Issues Public Health Alert for Summer Sausage Products Due to Possible Foreign Matter Contamination

Product Contamination

Radiator Cap May Leak or Spray Hot Coolant

An insufficiently sealed radiator cap may leak or spray hot coolant, increasing the risk of injury or crash.

Dealers will replace the radiator cap and refill any lost coolant, free of charge. Owner notification letters were mailed February 22, 2022. Owners may contact Honda service at 1-888-234-2138. Honda's number for this recall is KN1.

High Pressure Fuel Pump May Fail

Fuel pump failure can cause an engine stall while driving, increasing the risk of a crash.

Affected vehicle manufacturers will determine the appropriate remedy for their vehicles. Vehicle owners may contact the respective vehicle manufacturers customer service phone numbers listed in each vehicle manufacturer recall.

Damaged Driveshaft May Fracture

A fractured driveshaft can cause a loss of drive power, or a loss of vehicle control if the driveshaft contacts the ground. Additionally, unintended movement could occur while parked if the parking brake is not engaged. Any of these scenarios can increase the risk of a crash.

Dealers will inspect and repair the driveshaft as necessary, and properly attach the underbody insulators, free of charge. Owner notification letters were mailed February 4, 2022. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 21S56.

Spare Tire Incompatible with Accessory Wheels

An ABS system that does not function properly can increase the risk of a crash.

Dealers will provide a new 17" spare tire and wheel assembly that is compatible with the accessory wheels, free of charge. Dealers will also apply a new spare tire information label, and provide owners with an owner's manual insert clarifying which spare tire to use with the accessory road tires and with the 17" original tires. Owner notification letters were mailed February 7, 2022. Owners may contact GM customer service at 1-800-462-8782 or GMC customer service at 1-800-462-8782. GM's number for this recall is N212346510.

Cracks in Rear Tires

Cracks in the rear tires may result in rapid loss of tire pressure, which can lead to a loss of vehicle control, increasing the risk of a crash.

As an interim repair, dealers will replace the rear tires on the affected vehicles every 1,875 miles or when tire age reaches 1.5 years. Once newly designed tires are available, the tires will be replaced again. Repairs will be performed free of charge. Owners with tires that have already reached 2,500 miles or 1.5 years should not drive their vehicle until the tires are replaced. Owner notification letters were mailed on December 30, 2021. Owners may contact Bugatti customer service at 1-703-826-7545. Bugatti's number for this recall is BUGCR025.

Radar Module Misaligned

A misaligned radar module may prevent the vehicle from maintaining a safe distance from other vehicles when adaptive cruise control is active. In addition, the automatic emergency braking (AEB) system may react slowly, or not react at all, during a pre-collision assist braking event. Any of these scenarios can increase the risk of a crash.

Dealers will adjust the angle of the cruise control radar module, free of charge. Owner notification letters were mailed January 21, 2022. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 21S52.

Tailgate May Open Unexpectedly

Unexpected tailgate opening may allow unrestrained cargo to fall out of the truck bed and become a road hazard, increasing the risk of a crash.

Dealers will replace the left-hand and right-hand tailgate latches, free of charge. An interim notification letter was mailed January 31, 2022. Owner notification letters were mailed on May 31, 2022. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 21S53.

Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.

The incorrect product is contained in the packaging.

The recalling firm issued a recall letter dated 03 Dec 2021 on 12/3/2021 via Fed Ex Priority Overnight. The letter explained the packages labeled as the CLAW II 4 Hole Plates and the packages labeled as the DARCO Locking Screws were switched, resulting in the packages containing the incorrect product. The letter also provided the potential risks, the actions needed to be taken, and provided example labels of affected products. The consignee is to immediately check their inventory to locate the packaged product and remove them from their point of use. The enclosed business reply form was to be returned via email to confirm receipt of the letter and document product segregation. After the firm receives the reply form, the consignee will be contacted to arrange for return and replacement. The consignee was given the choice of providing subdistribution contact details to the recalling firm so the recalling firm could inform them of the recall, or the consignee can notify their downstream customers of the recall.

Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.

Elekta sent an Important Field Safety Notice 382-01-MON-007 was sent to all affected customers on November 17, 2016, to all affected customers. The notice informs users of the specific product version numbers affected by the issue, and any work arounds that can be used to avoid the issue. The notice included a reply form which is to be returned.

Fuel Tubes May Crack and Leak Fuel

A high pressure fuel leak in the presence of an ignition source can increase the risk of fire.

Dealers will replace the fuel tubes, and install vibration isolators, free of charge. Owners may contact Terex customer service at 1-800-678-5961.

Side Curtain Air Bag May Not Inflate Properly

An air bag that does not inflate properly can increase the risk of injury in a crash.

Dealers will replace the side curtain air bags, free of charge. An interim owner notification letter was mailed on February 3, 2022. Owner notification letters were mailed on April 22, 2022. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 21C37.

Improperly Attached Rear Seat Belts/FMVSS 208, 210

Improperly attached seat belts may not adequately restrain an occupant in a crash, increasing the risk of injury.

Dealers will repair the rear seat belt buckle attachments, free of charge. Owner notification letters were mailed January 28, 2022. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 21C36.

Driveshaft May Separate

Driveshaft separation can result in a loss of drive power, or unintended movement while parked if the parking brake is not engaged, increasing the risk of a crash.

Dealers will inspect and replace the driveshaft bolts. If any loose bolts are found, the driveshaft, attachment hardware, transfer case flange kit, and seal will also be replaced. Repairs will be performed free of charge. Owner notification letters were mailed February 4, 2022. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 21S54.

Fuel Tank Damage/FMVSS 301

A damaged fuel tank may result in a fuel leak, increasing the risk of a fire.

Dealers will inspect and replace the fuel tank as necessary, free of charge. Interim owner notification letters were mailed on January 28, 2022. Owner notification letters were mailed on March 15, 2022. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 21C35.

Incorrect Air Bag Information in Manual/FMVSS 208

The incorrect information may change how occupants position themselves in relation to the air bags, increasing the risk of injury in the event of a crash.

Bentley will mail new labels to owners. Owners may apply the label themselves or have a dealer apply the label, free of charge. Owner notification letters were mailed February 10, 2022. Owners may contact Bentley customer service at 1-800-777-6923. Bentley's number for this recall is RE21/43 (RC26).

Brake Line Routing May Cause Brake Fluid Leak

A brake fluid leak may cause partial or complete loss of the rear brakes, increasing the risk of a crash.

Dealers installed a kit to modify the rear brake caliper flexible line mounting, and inspected and replaced worn brake lines as necessary, free of charge. All affected vehicles have been repaired and therefore no owner notification letters will be sent. Owners may contact Arrow Manufacturing customer service at 1-712-261-3157.