Exactech, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2157-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: April 18, 2024
Date Posted: June 26, 2024
Recall Number: Z-2157-2024
Event ID: 94409
Reason for Recall:

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

Status: Ongoing
Product Quantity: N/A
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:

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated