CLASS II ONGOING Device recall · Reported 28 Oct 2020 · FDA Enforcement Report
Twinfix AB 5.0 Sutr Anchr W/2 38 Durab-Absorbable Suture recalled
Smith & Nephew is recalling Twinfix AB 5.0 Sutr Anchr W/2 38 Durab-Absorbable Suture anchors Product Number: 72200785, 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
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-0142-2021
- 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
TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
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 CaliforniaColoradoDelawareIllinoisIndianaPennsylvaniaPuerto Rico
Questions about this recall
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: 2044764
Where was it sold?
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
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.
Other products in this recall event
39 other products · FDA event 86462This product is part of a recall event; the main page for the event is Osteoraptor 2.3 W recalled by Smith & Nephew.
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
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| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |