Recall Z-2752-2016 ยท JDC Prosthesis, Elbow, Constrained, Cemented
Zimmer Biomet, Inc.
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
| Date | Sep 8, 2016 (initiated Aug 16, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | 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 us |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001989 | COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES Zimmer, Inc., Jul 25, 2000 |