CLASS II ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report

Biosure HA Screw Threaded metallic bone fixation fastener recalled

Smith & Nephew is recalling Biosure HA Screw Threaded metallic bone fixation fastener, distributed nationwide in the US. The recall was initiated on 24 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.

Quantity recalled168 units (US 83; OUS 85)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0957-2026
FDA event ID: 98051
Recalling firm: Smith & Nephew, Mansfield, MA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Nov 2025
FDA classified: 18 Dec 2025
Reported: 24 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

24 Nov 2025	Recall initiated by company
18 Dec 2025	Classified by FDA	+24 days
24 Dec 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Removal of affected lot of screws due to labeling error.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama California Colorado Florida Iowa Illinois Kentucky Minnesota North Carolina Nebraska New York Oklahoma Tennessee Texas Utah

Questions about this recall

Why was it recalled?

Removal of affected lot of screws due to labeling error.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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