Recall Z-1098-2023 ยท HTO Reamer
Zimmer, Inc.
Identity Shoulder System Resection Planer 35mm Resection Planer
| Date | Feb 6, 2023 (initiated Dec 7, 2022) |
| Status | Open, Classified |
| Reason | Two planers were found to be unusable during sawbones shoulder training. |
| Root cause | Process control |
| Action | Consignee notification was made to impacted distributors and hospitals beginning December 27, 2022. Consignees are asked to immediately check inventory and quarantine any impacted devices. Return of product is to be made to Zimmer Biomet via an Inventory Return Certification Form. This form shall be completed even if there is no impacted inventory. |
| Quantity | 84 units |
| Distribution | US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.