CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report

Bioraptor Suture Anchors recalled by Smith & Nephew

Smith & Nephew is recalling Bioraptor Suture Anchors, distributed nationwide in the US. The recall was initiated on 29 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.

Quantity recalled2,156 units

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-0581-2025
FDA event ID: 95654
Recalling firm: Smith & Nephew, Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 29 Oct 2024
FDA classified: 29 Nov 2024
Reported: 11 Dec 2024
Type: Voluntary: Firm initiated
Reason category: Sterility
Device type: Surgical Instruments

Timeline

29 Oct 2024	Recall initiated by company
29 Nov 2024	Classified by FDA	+31 days
11 Dec 2024	Published in enforcement report	+12 days

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

Reason for recall

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

Where it was distributed

Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.

Nationwide Alaska Alabama California Illinois Indiana Kentucky Maryland Minnesota North Carolina Nebraska New Hampshire New Jersey Texas

Questions about this recall

Why was it recalled?

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

Which lots are affected?

Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.

Where was it sold?

Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.

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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