Exactech, Inc.: 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;

Hazard

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

Details from the source

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: Worldwide distribution. Quantity: N/A Lot/code info: 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, 6910758, 6910759, 6910761, 6910778, 6910788, 7017895; b) 200-02-29, UDI/DI 10885862039583, Lot Numbers: 5879069, 6007378, 6007384, 6160756, 6160758, 6516483, 6530381, 6530425, 6631144, 6666877, 6666893, 6716571, 6716613, 6721823, 6741812, 6857688, 6919108, 6083494, 6530382, 6555638, 6979180, 6005908, 6005941, 6160736, 6160755, 6516968, 6559612, 6673204, 6803850, 6881661, 6110574, 6160509, 6982513, 6555598, 6555750, 5901678, 6530553, 6530562, 6709794, 6866198, 6530428, 6530534, 6530571, 6631384, 67250

UPC codes

10885862039576, 10885862039583, 10885862039590, 10885862039606, 10885862039613, 10885862039620

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.