Smith & Nephew Inc.: BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

Hazard

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

Details from the source

Reason for recall: Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR. Quantity: 2,156 units Lot/code info: Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.

UPC codes

03596010595072, 03596010595089, 03596010656452, 03596010656469

Source

Official record: FDA (Device enforcement) ↗

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