Recall Z-3177-2018 ยท HWC Screw, Fixation, Bone
Zimmer Biomet, Inc.
Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629
| Date | Jul 20, 2018 |
| Status | Terminated |
| Reason | The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled. |
| Root cause | Process control |
| Action | On 7/20/18, Urgent Medical Device Recall notification letters were sent to customers. The letters instructed customers to do the following: Risk Managers: 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. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form |
| Quantity | 52 |
| Distribution | The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982497 | ARTHROTEK INTERFERENCE SCREW Biomet, Inc., Oct 16, 1998 |