# FDA recall Z-0526-2020

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

## Product

Various Custom Products, Item Nos. CP102940  CP102941  CP102942  CP102943  CP102944  CP102945  CP102946  CP102947  CP102948  CP112662  CP112663  CP112664  CP112674  CP112675  CP113771  CP113777  CP113778  CP113782  CP113783  CP114083  CP114090  CP114112  CP114118  CP114148  CP114213  CP114388  CP114436  CP114463  CP114472  CP114478  CP114495  CP114532  CP114561  CP114563  CP114605  CP114695  CP114756  CP114782  CP114783  CP114933  CP114987  CP115008  CP115048  CP115049  CP115050  CP115166  CP115209  CP115212  CP115312  CP115313  CP115314  CP115318  CP115319  CP115320  CP115322  CP115357  CP115358  CP115359  CP115360  CP115362  CP115363  CP115371  CP161304  CP161305  CP161306  CP161307  CP161522  CP161560  CP161735  CP161741  CP161751  CP161752  CP161753  CP161768  CP161793  CP161795  CP161831  CP161867  CP162006  CP162007  CP162008  CP162013  CP162017  CP162042  CP162043  CP162055  CP162084  CP162085  CP162086  CP162121  CP162149  CP162150  PM0000711  PM103016  PM103022  PM103060  PM15

## 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-0526-2020
- **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-0526-2020

## Citation

> AI Analytics. FDA recall Z-0526-2020. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0526-2020. Source: US FDA. Licensed CC0.

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