Recall Z-0517-2020 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
ASI 2.0 Calcar Trimmer Shaft for Use with Biomet Rasp, Model Number 110032331
| Date | Aug 6, 2019 |
| Status | Terminated |
| Reason | The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331. |
| Root cause | Under Investigation by firm |
| Action | On August 9, 2019 the firm distributed Urgent Medical Device Recall Communication letters by email instructing them to: 1. Review this 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 Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. This form must be returned even if you do not h |
| Quantity | 73 |
| Distribution | CA, IN, MN, NJ, NY, AR, LA, OH, KY, TX, CO (US) CA, CN, NL (International) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.