Class II

Medical Device Recall: OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

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-2155-2024

Status: ongoing

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