Universal Chuck-The Universal Chuck is an Instrument Handle provided… — Class II medical device recall Z-0634-2022
Ongoing recall by Synthes (USA) Products LLC, reported 2022-02-16, distributed nationwide. Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the
| Recall number | Z-0634-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2021-12-22 |
| Classified | 2022-02-10 |
| Reported by FDA | 2022-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 600 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10886982297372 |
| Serial numbers | 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201, 21869701, 21983904, 21995301 |
Product
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding instruments for manipulation during orthopedic surgery. Product No.: 03.043.001
Reason for recall
Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0634-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.