# FDA recall Z-0328-2020

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

## Product

Various fixation systems and accessories, Item Nos. 00224000916  00224000918  00224000920  00224000922  00224000924  00224000926  00224000928  00224000930  00224000932  00224000934  00224000936  00224000938  00224000940  00224000942  00224000944  00224000946  00224001014  00224001016  00224001018  00224001020  00224001022  00224001024  00224001026  00224001028  00224001030  00224001032  00224001034  00224001036  00224001038  00224001040  00224001042  00224001046  00224001048  00224001114  00224001116  00224001118  00224001120  00224001122  00224001124  00224001126  00224001128  00224001130  00224001132  00224001134  00224001136  00224001138  00224001140  00224001142  00224001144  00224001146  00224001214  00224001216  00224001218  00224001220  00224001222  00224001224  00224001226  00224001228  00224001230  00224001232  00224001234  00224001236  00224001238  00224001240  00224001242  00224001244  00224001246  00224001248  00224001314  00224001316  00224001318  00224001320  00224001322 

## Reason for recall

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

## Distribution

Distributed nationwide.

## Key facts

- **Recall number:** Z-0328-2020
- **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-0328-2020

## Citation

> AI Analytics. FDA recall Z-0328-2020. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-0328-2020. Source: US FDA. Licensed CC0.

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