Zimmer Dental Inc Recalls

Tapered Screw-Vent MTX Model TSVTB11

Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.

Recall notification letters will be sent to distributors and clinicians on or about the last week of November 2017. International distributors will be notified via courier or email. Clinicians will be instructed to; 1. Follow any specified patient monitoring instructions, 2. Return Attachment 1 (Acknowledgment of Responsibility) to Zimmer Biomet, 3. Review their inventory and returning any affected product.

Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.

The firm, Zimmer Biomet, sent an "Medical Device Recall" notice dated 5/10/2018 via FedEx/UPS courier to its customers. OUS distributors received a "distributor" notice. The notice described the product, problem and actions to be taken. The Customers were instructed to immediately return affected product to Field Action, PM Regulatory Compliance, Zimmer Biomet, 4555 Riverside Dr., Palm Beach Gardens, FL 33410 US and asked to complete and return a Certificate of Acknowledgement. and send to CorporateQuality.PostMarket@zimmerbiomet.com. If you have further questions or concerns, please call the Recall Department at 561-776-6700 between 8:00 am and 5:00 pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223

Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.

The affected customers are being provided instructions on how to obtain the supplemental IFUs for respective part numbers from appropriate E-labeling website along with a recall notice.

Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with en

The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.

The recalling firm, Zimmer Biomet, issued "URGENT MEDICAL DEVICE RECALL" letters addressed to Clinicians dated 10/11/2017 via FedEx on 10/11/2017. Letters to the distributors dated 10/11/2017 were issued via courier or email on 10/11/2017. The letters described the product, problem and actions to be taken. The customers were instructed to review notification for awareness; review your inventory; immediately return all affected product from your facility to: Field Action PM Regulatory Compliance Zimmer Biomet 4555 Riverside Dr. Palm Beach Gardens, FL 33410 US and complete and return the Certificate of Acknowledgment by fax to 574-372-4265 or email: CorporateQuality.Postmarket@zimmberbiomet.com. If you have further questions or concerns after reviewing this notice, please call the Recall Department at 561-776-6700 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.

Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.

On 11/29/2017, customers were notified via letter. Instructions for distributors include to ensure that affected team members are aware of the recall, immediately locate and quarantine affected devices in inventory, notify consignees if product was distributed, make arrangements to immediately return affected devices, and complete and return the Attachment 1 - Inventory Return Certification Form. Instructions for clinicians include to review the recall notice, examine inventory for affected devices, complete and return the Attachment 2 - Certificate of Acknowledgement, and return all affected devices.

Tapered SwissPlus Implant System, Model No. SPB10

It was manufactured with the minor diameter of the internal thread that is below specification.

A customer letter was sent on 3/20/17 to inform customers that Zimmer Biomet is recalling a single lot of the Tapered SwissPlus 3.7mmD Implant, Lot No. 63498673. The letter informs customers that the recall is due to one (1) lot of part number SPB10 (lot 63498673) that was manufactured with the minor diameter of the internal thread below specification. This condition may cause mating issues with some screws. The condition occurs when the screw used has a minor thread diameter that is closer to the maximum allowed diameter (maximum material condition). However, screws closer to the least material condition will still fit into the implant. Customers with questions or concerns are instructed to call the customer call center at 1-800-854-7091 between 8:00 am and 5:00pm EST, Monday through Friday. Customers are also instructed to email to corporatequality.postmarket@zimmerbiomet.com.

IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.

Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form. It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records. For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.

GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages the Fixture Mount Transfer (FMT) to transport the dental implant from the product packaging to the osteotomy.

The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.

An Urgent Device Recall Notice was sent on 1/22/15 to their domestic and foreign customers who purchased the Gemlock Long Hex Driver. The letter informs the customers of the problems identified, risks, and the actions to be taken. Customers are instructed to review the notice and check their inventory for the affected units. All affected product is to be immediately quarantined and removed from service. Customers are to contact Simmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and set up return of the products. Customers should complete the attached Business Reply Form and fax it to (574) 372-4265 or e-mail to corporatequality.postmarket@zimmer.com. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019, Mon-Fri, 7 am-5pm (Pacific). Zimmer Dental is expanding the recall to include 1 additional lot for catalog no.TSVKIT. Zimmer Dental plans to inform an amended customer notification letter to their US and foreign consignees. The letter will go out to customers on 4/20/15 to inform them of the expanded lot.

Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.

Customer Notification letters dated 10/6/14 were sent to all customers who purchased the Tapered Screw Vent Implant and the Spline Twist Implant because the incorrect diameter size was printed on the inner vial. The letters informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached Business Reply Form and fax it to (574) 372-4265 or email to corporatequality.postmarket@zimmer.com. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019 from 7am-5pm, Monday-Friday.

Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state 3.7 x 10mm instead of 4.7 x 11.5mm.

Zimmer Dental initiated the recall on 01/06/2013 by sending out recall notifications via FedEx to domestic customers and via electric mail to international customers. Customers are sent a letter identifying the issue, product description with codes, risk, instructions, and contact information. The letter's instructions include locating the affected product and return unused product to Zimmer Dental and notifying the amount of product that has been consumed.

Advent Implant Line

Sterility barrier compromised.