Recall Z-1086-2019 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
| Date | Mar 1, 2019 |
| Status | Terminated |
| Reason | Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa. |
| Root cause | Packaging process control |
| Action | Zimmer Biomet conducted recall by letter dated 3/1/19 to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors via email. Hospital risk managers and surgeons, as well as distributors with product notified Fed'x. Accounts asked to review notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory.3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.a. Complete Attachment 1 Inventory Return Cer |
| Quantity | 809 total |
| Distribution | Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912245 | AGC REVISION KNEE PROTHESIS Biomet, Inc., Aug 19, 1991 |