# FDA recall Z-0321-2020

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2019-10-10.

## Product

Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100  00522000200  00522000300  00522000400  00522006304  00522006504  00522006600  00522006800  00522006900  00522007000  00522007200  00522007300  00522007400  00522007500  00522007900  00522008000  00522400800  00522400900  00522406201  00541001401  00541001501  00541001502  00541001601  00541001602  00541001701  00541001702  00541001801  00541001802  00541201501  00541201502  00541201601  00541201602  00541201701  00541201702  00541201801  00541201802  00541401301  00541401302  00541401401  00541401402  00541401501  00541401502  00541401601  00541401602  00541401701  00541401702  00541601401  00541601402  00541601501  00541601502  00541601601  00541601602  00575001301  00575001302  00575001305  00575001306  00575001401  00575001402  00575001405  00575001406  00575001501  00575001502  00575001505  00575001506  00575001601  00575001602  00575001605  00575001606  00575001701  00575001702  00575001705  

## Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

## Distribution

Distributed nationwide.

## Key facts

- **Recall number:** Z-0321-2020
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-10
- **Report date:** 2019-11-13
- **Termination date:** 2020-05-19

- **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-0321-2020

## Citation

> AI Analytics. FDA recall Z-0321-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0321-2020. Source: US FDA. Licensed CC0.

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