FDA-Device2024-06-26Class II
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
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 One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2156-2024Don't want to check this manually?
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