—#139083

Product

ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

FDA product code: OJH — Orthopedic Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Code:900741A Lots: 140915516 exp. 11/30/15 150116509 exp. 12/31/15 150116510 exp. 12/31/15 150317657 exp. 3/31/16 150318094 exp. 3/31/16 150318095 exp. 3/31/16 150318197 exp. 4/30/16 150318196 exp. 4/30/16 150318198 exp. 4/30/15 150518839 exp. 5/31/16 150619189 exp. 6/30/16 150619406 exp. 6/30/16

Why it was recalled

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Root cause (FDA determination)

Packaging

Action the firm took

Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.

Recalling firm

Firm: Customed, Inc Calle Igualdad Final # 7
Address: Fajardo, Puerto Rico 00738

Distribution

Distribution pattern: Distributed Only in Puerto Rico.

Timeline

Recall initiated: 2015-07-10
Posted by FDA: 2015-09-03
Terminated: 2017-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139083. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.