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

Medical DevicesSource: FDA (device) · Date: 2025-12-24

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Smith & Nephew, Inc.
Product
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Reason / hazard
Removal of affected lot of screws due to labeling error.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2025-11-24
Code info
Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
Product quantity
168 units (US 83; OUS 85)
Voluntary mandated
Voluntary: Firm initiated
City
Mansfield
State
MA
Country
United States
Event id
98051
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