PlainRecalls
FDA Devices Moderate Class II Ongoing

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;

Reported: June 26, 2024 Initiated: April 18, 2024 #Z-2155-2024

Product Description

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;

Reason for Recall

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

Details

Recalling Firm
Exactech, Inc.
Units Affected
N/A
Distribution
Worldwide distribution.
Location
Gainesville, FL

Frequently Asked Questions

What product was recalled?
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;. Recalled by Exactech, Inc.. Units affected: N/A.
Why was this product recalled?
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 26, 2024. Severity: Moderate. Recall number: Z-2155-2024.