SUTUREFIX ULTRA Suture — Class II medical device recall Z-2746-2020
Ongoing recall by Smith & Nephew, Inc., reported 2020-08-12, distributed in AL, AR, AZ, CO, GA, IL, IN, KS…. A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one i
| Recall number | Z-2746-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Andover, MA, United States |
| Recall initiated | 2020-06-24 |
| Classified | 2020-07-31 |
| Reported by FDA | 2020-08-12 |
| Distributed | AL, AR, AZ, CO, GA, IL, IN, KS, KY, MD, MN, MO, NC, NE, NJ, NY, OK, PA, PR, TN, TX, VA, WI |
| Countries outside the US | AT, AU, BE, CH, DE, ES, FI, FR, GB, IE, IT, JP, LU, MX, NL, PL, PT, SE, SG, ZA |
| Quantity | 868 |
| Lot numbers | 2038366, 2039311, 2046505 |
Product
SUTUREFIX ULTRA Suture, Product number 72203855
Reason for recall
A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2746-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.