FDA-Device2024-06-26Class II

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

Exactech, Inc.
Hazard

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

Sold states
Worldwide distribution.
Affected count
N/A
Manufactured in
2320 Nw 66th Ct, N/A, Gainesville, FL, United States
Products
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2157-2024

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