Class II

Medical Device Recall: OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM

Exactech, Inc. · April 18, 2024

Reason for Recall

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

Distribution

Worldwide distribution.

Quantity Affected

N/A

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2157-2024

Status: ongoing

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