Home / Recalls / Exactech, Inc. / Z-2157-2024

Z-2157-2024 Class II Ongoing

Recalled by Exactech, Inc. — Gainesville, FL

Recall Details

Product Type
Devices
Report Date
June 26, 2024
Initiation Date
April 18, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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

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 Pattern

Worldwide distribution.

Code Information

a) 200-05-23, UDI/DI 10885862039835, Lot Numbers: b) 200-05-26, UDI/DI 10885862039842, Lot Numbers: c) 200-05-29, UDI/DI 10885862039859, Lot Numbers:

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