Recall Z-0803-2018 ยท JEB Table, Surgical With Orthopedic Accessories, Manual
Zimmer Biomet, Inc.
The 2nd Assist Knee Positioner
| Date | Sep 7, 2017 |
| Status | Terminated |
| Reason | Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution. |
| Root cause | Package design/selection |
| Action | On September 12, 2017 an URGENT MEDICAL DEVICE RECALL notice was issued to distributors and customers titled "The Second Assistant Disposable Knee Positioner". The notice requests customers to review their inventory and to quarantine any remaining product, which will be returned to the firm. Also, to notify any additional accounts which may have received product from you. Questions or concerns can be directed to Customer Service at 574-371-3071 |
| Quantity | 38,879 units |
| Distribution | Nationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.