# FDA recall Z-0520-2020

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

## Product

COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S  115331  115330S  115330  110040610  110040620  010000589  CP561861  PM0001456  PM551047  PM551063  PM555137  PM555160  PM555209  PM555322  PM555406  PM555415    UDI:    (01)00880304475342(17)211128(10)704850  (01)00880304475342(17)220128(10)094500  (01)00880304475342(17)220328(10)856620  (01)00880304475342(17)220528(10)487710  (01)00880304475342(17)220628(10)028860  (01)00880304475342(17)220628(10)028870  (01)00880304475342(17)220628(10)799030  (01)00880304475342(17)220628(10)799070  (01)00880304475342(17)220628(10)929900  (01)00880304532465(17)220628(10)850060  (01)00880304475342(17)220628(10)803010  (01)00880304532465(17)220728(10)026780  (01)00880304475342(17)220828(10)208370  (01)00880304475342(17)220901(10)811210R  (01)00880304475342(17)221028(10)960160  (01)00880304532465(17)221028(10)943820  (01)00880304475342(17)240616(10)237420  (01)00880304475342(17)230909(10)500790  (01)00880304475342(17)221128(1

## 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-0520-2020
- **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-0520-2020

## Citation

> AI Analytics. FDA recall Z-0520-2020. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-0520-2020. Source: US FDA. Licensed CC0.

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