Smith & Nephew, Inc.: BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Hazard

Removal of affected lot of screws due to labeling error.

Details from the source

Reason for recall: Removal of affected lot of screws due to labeling error. Distribution: US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN, NC, NE, NY, OK, TN, TX, UT; OUS (Foreign) to countries of: Australia, Czech Republic, Finland, France, Germany, Indonesia, Italy, Malaysia, Martinique, Mexico, Netherlands, Norway, Poland, Singapore, Switzerland. Quantity: 168 units (US 83; OUS 85) Lot/code info: Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.

UPC codes

03596010611642, 00885554036572

Source

Official record: FDA (Device enforcement) ↗

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