STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0 — Class II medical device recall Z-0150-2023
Ongoing recall by Ethicon, Inc., reported 2022-11-09. Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more
| Recall number | Z-0150-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2022-09-20 |
| Classified | 2022-10-31 |
| Reported by FDA | 2022-11-09 |
| Countries outside the US | CN |
| Quantity | 2,280 eaches |
| UPC / GTIN / UDI-DI | 10705031228061 |
| Serial numbers | B903HPU |
| Expiration dates | 2026-08-21 |
Product
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
Reason for recall
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
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-0150-2023. 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.