CORIN MEDICAL, LTD.: Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-501

Hazard

Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

Details from the source

Reason for recall: Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches. Distribution: US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT. Quantity: 341 units Lot/code info: Model Number (Serial Numbers): KC-50090(580854, 582278), KC-50097(528456, 528457), KC-50110(531527, 532301, 586311), KC-50117(552924), KC-50130(528458, 548885, 548886, 548887, 548888, 573259), KC-50135(529093), KC-50137(527387, 528459, 555044, 568751), KC-50150(529072, 529094, 565748, 584973, 584974), KC-50155(586369), KC-50157(528460, 528461, 545943, 565831, 565832, 567009, 572398, 587261, 587262), KC-50170(528462, 529076, 550671, 585011), KC-50175(552532), KC-50177(529073, 588382), KC-50190(529074), KC-50197(548468, 548469, 548470), KC-52104(584975), KC-52554(589609), KC-52574(586115, 586117), KC-52774(584976), KC-55223(580117), KC-55243(580855).

Source

Official record: FDA (Device enforcement) ↗

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