Recall Z-1224-2018 ยท JHW U.V. Method, Cpk Isoenzymes
Zimmer Biomet, Inc.
PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
| Date | Dec 12, 2017 |
| Status | Terminated |
| Reason | A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug. |
| Root cause | Under Investigation by firm |
| Action | On December 12, 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers will the following guidance: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. Questions or concerns can be directed to 1-574-371-3071. |
| Quantity | 3 units |
| Distribution | Non-USA Customer |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122765 | PERSONA NATURAL TIBIA BASEPLATES Zimmer, Inc., Nov 9, 2012 |