# FDA recall Z-0634-2022

> **Synthes (USA) Products LLC** · Class II · device recall initiated 2021-12-22.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0634-2022
- **Recalling firm:** Synthes (USA) Products LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-22
- **Report date:** 2022-02-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0634-2022

## Citation

> AI Analytics. FDA recall Z-0634-2022. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0634-2022. Source: US FDA. Licensed CC0.

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