CLASS II ONGOING Device recall · Reported 28 Oct 2020 · FDA Enforcement Report

Osteoraptor Crvd 3 SA UB Cobrd Blue- Absorbable Suture recalled

Smith & Nephew is recalling Osteoraptor Crvd 3 SA UB Cobrd Blue- Absorbable Suture anchor Product Number: 72203290, distributed nationwide in the US. The recall was initiated on 9 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch Numbers: 2012935 2013910 2016229 2017812 2018635 2019990 2021454 2022268 2024711 2025147 2027400 2029394 2030945 2037184 2038460 2038795 2039253 2039444 2045859 2045858 2045860 2045861 2048368 2049884 2048367

Quantity recalled263,874 (total)

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-0165-2021
FDA event ID: 86462
Recalling firm: Smith & Nephew, Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Sep 2020
FDA classified: 21 Oct 2020
Reported: 28 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

9 Sep 2020	Recall initiated by company
21 Oct 2020	Classified by FDA	+42 days
28 Oct 2020	Published in enforcement report	+7 days

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

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

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

OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290

Where it was distributed

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

Nationwide California Colorado Delaware Illinois Indiana Pennsylvania Puerto Rico

Questions about this recall

Is Osteoraptor Crvd 3 SA UB Cobrd Blue- Absorbable Suture anchor Product Number: 72203290 recalled?

Yes. Smith & Nephew recalled Osteoraptor Crvd 3 SA UB Cobrd Blue- Absorbable Suture anchor Product Number: 72203290 on 9 Sep 2020. The recall is Class II and its status is Ongoing. Recall number Z-0165-2021.

Why was it recalled?

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Which lots are affected?

Batch Numbers: 2012935 2013910 2016229 2017812 2018635 2019990 2021454 2022268 2024711 2025147 2027400 2029394 2030945 2037184 2038460 2038795 2039253 2039444 2045859 2045858 2045860 2045861 2048368 2049884 2048367

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 21 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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2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide