Recall Z-0871-2020 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument
| Date | Dec 19, 2019 |
| Status | Terminated |
| Reason | Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach |
| Root cause | Process control |
| Action | Zimmer Biomet issued letter via email and FedEx on 12/17/19 stating reason for recall, health risk and action to take: 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. Questions or concerns after reviewing this notice, |
| Quantity | 67 units |
| Distribution | US Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.