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Z-0957-2026Class II

Smith & Nephew, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Smith & Nephew, Inc.
Product type
Device
Status
Ongoing
Report date
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.
Firm state
MA
Product quantity
168 units (US 83; OUS 85)
Initiated by
Voluntary: Firm initiated
Reason for recall

Removal of affected lot of screws due to labeling error.

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →