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

Healicoil RSB SA W/1 UT & 1 UB BK-- Absorbable Suture recalled

Smith & Nephew is recalling Healicoil RSB SA W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705, 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: 2013957 2013995 2013996 2016209 2016207 2017775 2017860 2018647 2019852 2019853 2021462 2023240 2023345 2024841 2024742 2026562 2025370 2025438 2027467 2025207 2027434 2027500 2027405 2029350 2029351 2030952 2031022 2031088 2031089 2031156 2033536 2034426 2035500 2034498 2037191 2037151 2039451 2039609 2041070 2042597 2042777 2048390 2048391 2049913 2051216 2049914 2051654 2051655 2051656 2051657 2053912 2053913 2056080 2056081 2056426

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-0169-2021
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

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705

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 Healicoil RSB SA W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705 recalled?

Yes. Smith & Nephew recalled Healicoil RSB SA W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705 on 9 Sep 2020. The recall is Class II and its status is Ongoing. Recall number Z-0169-2021.

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: 2013957 2013995 2013996 2016209 2016207 2017775 2017860 2018647 2019852 2019853 2021462 2023240 2023345 2024841 2024742 2026562 2025370 2025438 2027467 2025207 2027434 2027500 2027405 2029350 2029351 2030952 2031022 2031088 2031089 2031156 2033536 2034426 2035500 2034498 2037191 2037151 2039451 2039609 2041070 2042597 2042777 2048390 2048391 2049913 2051216 2049914 2051654 2051655 2051656 2051657 2053912 2053913 2056080 2056081 2056426

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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