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

Ultra Fast-fix AB Assembly - Curved-Absorbable Suture recalled

Smith & Nephew is recalling Ultra Fast-fix AB Assembly - Curved-Absorbable Suture anchors Product Number: 72201494, 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: 2023195 2023243 2024953 2024956 2025090 2025122 2025379 2025380 2026563 2028643 2027357 2027362 2027367 2027371 2029177 2029178 2029179 2029180 2029213 2030836 2030837 2030853 2030854 2030869 2030870 2030871 2030872 2030883 2030884 2032840 2033307 2033418 2033554 2035383 2035384 2035403 2035404 2035413 2035428 2036762 2036763 2037209 2038262 2040397 2040398 2039496 2039175 2039633 2039634 2041088 2041089 2041214 2044784 2042798 2044783 2045734 2045735 2046221 2048174 2048173 2048175 2048176 2048177 2049628 2049629 2049630 2049631 2049632 2050866 2050867 2051658 2050868 2050869 2052035 2053332 2053334 2050865 2053333 2053335 2053336 2053337 2054832 2055528 2054776 2054777 2054778

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-0144-2021
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

ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

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 Ultra Fast-fix AB Assembly - Curved-Absorbable Suture anchors Product Number: 72201494 recalled?

Yes. Smith & Nephew recalled Ultra Fast-fix AB Assembly - Curved-Absorbable Suture anchors Product Number: 72201494 on 9 Sep 2020. The recall is Class II and its status is Ongoing. Recall number Z-0144-2021.

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: 2023195 2023243 2024953 2024956 2025090 2025122 2025379 2025380 2026563 2028643 2027357 2027362 2027367 2027371 2029177 2029178 2029179 2029180 2029213 2030836 2030837 2030853 2030854 2030869 2030870 2030871 2030872 2030883 2030884 2032840 2033307 2033418 2033554 2035383 2035384 2035403 2035404 2035413 2035428 2036762 2036763 2037209 2038262 2040397 2040398 2039496 2039175 2039633 2039634 2041088 2041089 2041214 2044784 2042798 2044783 2045734 2045735 2046221 2048174 2048173 2048175 2048176 2048177 2049628 2049629 2049630 2049631 2049632 2050866 2050867 2051658 2050868 2050869 2052035 2053332 2053334 2050865 2053333 2053335 2053336 2053337 2054832 2055528 2054776 2054777 2054778

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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