Recall Z-2752-2016
Zimmer Biomet, Inc. · initiated August 16, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the outer cavity. The patient record label is placed on the Tyvek outerlid. The sealed cavities and package insert is placed into a folding carton, sealed and shrink wrapped. Total elbow prosthesis designed for use with bone cement
Codes / lots: Item Number: 32-8105-027-01 Lot Number: 62811341
Reason for recall
Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing could result in a surgical delay or additional surgery if a replacement is not available.
FDA-determined cause: Process design
Action taken
Zimmer Biomet sent an Urgent Medical Device Recall Removal letter dated August 16, 2016, for their C/M Elbow Pin/ Bushing Replacement Kit via FedEx. All distributors were notified via electronic mail. Hospital risk managers, as well as distributors with product, were notified via courier. Customers were instructed to complete the following items including locating and removing the product in their territory, as well as identifying hospitals that currently have the affected product. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers were provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Attachment 1 form. - Complete and return Attachment 1 (Acknowledgement of Responsibility) to the fax number or email address provided. If there are questions or concerns please call the customer call center at 1-800-348-9500 ext 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com. For questions regarding this recall call 877-946-2761.
Details
- Recall number
- Z-2752-2016
- Initiated
- August 16, 2016
- Posted by FDA
- September 8, 2016
- Terminated
- June 12, 2017
- Product code
- JDC – Prosthesis, Elbow, Constrained, Cemented
- Quantity
- 25 units
- Distribution
- Worldwide Distribution - US including AL, AZ, CA, CT, GA, MN, NC, OH, OR and Internationally to Australia, Germany, Japan, Korea, and Taiwan.
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN