# FDA recall Z-0532-2020

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2019-08-21.

## Product

LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC;  LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC;  DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices          Item Nos. 114754  114755  114744  114745  114704  114705  114756  114757  114714  114715  114746  114747  114706  114707  114758  114759  114716  114717  114748  114749  114708  114709  114718  114719  CP561429  CP561430  CP561431  CP561432  CP561442  CP561449  CP561488  CP561489  CP561709  CP561710  CP561714  CP561715  PM555203  Product Usage: Total Elbow Replacement

## Reason for recall

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

## Distribution

US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.

## Key facts

- **Recall number:** Z-0532-2020
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-21
- **Report date:** 2019-12-04
- **Termination date:** 2021-07-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0532-2020

## Citation

> AI Analytics. FDA recall Z-0532-2020. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-0532-2020. Source: US FDA. Licensed CC0.

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