FDA Device recall Z-2155-2024

OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM

FDA Device
Class II
ongoing
Published 2024-06-26

On 2024-06-26 the FDA classified a Class II recall of OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM by Exactech, citing exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2155-2024
Classification	Class II
Status	ongoing
Initiated	2024-04-18
Published	2024-06-26
Last updated	2026-09-13 11:57 UTC
Company	Exactech
Distribution	n/a

Product

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

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

Identifiers

code_info	a) 200-02-26, UDI/DI 10885862039576, Lot Numbers: 5881807, 5908515, 5968530, 6007309, 6038708, 6038717, 6066779, 63454… a) 200-02-26, UDI/DI 10885862039576, Lot Numbers: 5881807, 5908515, 5968530, 6007309, 6038708, 6038717, 6066779, 6345487, 6345502, 6358520, 6431224, 6431231, 6551547, 6557360, 6723682, 6734364, 6771158, 6865729, 6910696, 6910715, 6910718, 6910745, 6910752, 6910779, 7017876, 5968531, 6161207, 6383171, 6358523, 6601196, 6910805, 6066775, 6424212, 6431232, 7017878, 6406114, 6601148, 6161158, 6161182, 6470948, 6470955, 5968547, 6004184, 6383177, 6514106, 6551513, 6551531, 6551534, 6601150, 6672159, 6723663, 6723679, 6910704, 6007300, 6007323, 6007306, 6383158, 6181021, 6530351, 6530359, 6910787, 6514153, 6557339, 6557341, 6066789, 6457006, 6007299, 6530338, 6601188, 6621896, 6672158, 6865746, 6910794, 6004190, 6601141, 6601180, 6716699, 6716716, 7017894, 6038704, 6038713, 6457023, 6530356, 6668072, 6672152, 6723670, 6723690, 6038746, 6203999, 6371789, 6371797, 6371819, 6424210, 6431226, 6601165, 6601181, 6601195, 6672143, 6672148, 6734373, 6865718, 6865731, 6865736, 6865748, 6865750, 6910

code_info

a) 200-02-26, UDI/DI 10885862039576, Lot Numbers: 5881807, 5908515, 5968530, 6007309, 6038708, 6038717, 6066779, 63454…

a) 200-02-26, UDI/DI 10885862039576, Lot Numbers: 5881807, 5908515, 5968530, 6007309, 6038708, 6038717, 6066779, 6345487, 6345502, 6358520, 6431224, 6431231, 6551547, 6557360, 6723682, 6734364, 6771158, 6865729, 6910696, 6910715, 6910718, 6910745, 6910752, 6910779, 7017876, 5968531, 6161207, 6383171, 6358523, 6601196, 6910805, 6066775, 6424212, 6431232, 7017878, 6406114, 6601148, 6161158, 6161182, 6470948, 6470955, 5968547, 6004184, 6383177, 6514106, 6551513, 6551531, 6551534, 6601150, 6672159, 6723663, 6723679, 6910704, 6007300, 6007323, 6007306, 6383158, 6181021, 6530351, 6530359, 6910787, 6514153, 6557339, 6557341, 6066789, 6457006, 6007299, 6530338, 6601188, 6621896, 6672158, 6865746, 6910794, 6004190, 6601141, 6601180, 6716699, 6716716, 7017894, 6038704, 6038713, 6457023, 6530356, 6668072, 6672152, 6723670, 6723690, 6038746, 6203999, 6371789, 6371797, 6371819, 6424210, 6431226, 6601165, 6601181, 6601195, 6672143, 6672148, 6734373, 6865718, 6865731, 6865736, 6865748, 6865750, 6910

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2155-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.