Class IIReported 2025-12-24

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Recalled by Smith & Nephew, Inc.

Reason for Recall

Removal of affected lot of screws due to labeling error.

Recall Number

Z-0957-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-11-24

Reported

2025-12-24

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.

Code Info

Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.