# FDA recall Z-0349-2020

> **Synthes (USA) Products LLC** · Class II · device recall initiated 2019-09-05.

## Product

MODIFIED INSTRUMENTS:  Trial Spacer 7mm with T-Handle  Trial Spacer 8mm with T-Handle  Trial Spacer 9mm with T-Handle  Trial Spacer 10mm with T-Handle  Trial Spacer 11mm with T-Handle  Trial Spacer 12mm with T-Handle  Trial Spacer 13mm with T-Handle  Trial Spacer 15mm with T-Handle  Trial Spacer 17mm with T-Handle

## Reason for recall

Modified outside of approved manufacturing process

## Distribution

AR

## Key facts

- **Recall number:** Z-0349-2020
- **Recalling firm:** Synthes (USA) Products LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-05
- **Report date:** 2019-11-20
- **Termination date:** 2020-06-23

- **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-0349-2020

## Citation

> AI Analytics. FDA recall Z-0349-2020. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0349-2020. Source: US FDA. Licensed CC0.

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