Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile… — Class II medical device recall Z-0655-2020
Ongoing recall by CP Medical Inc, reported 2019-12-18, distributed in CA, FL, IA, KY, NE, OH, PA, SC…. Failed to meet USP minimum average value for knot pull (tensile) strength.
| Recall number | Z-0655-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CP Medical Inc, Norcross, GA, United States |
| Recall initiated | 2019-10-18 |
| Classified | 2019-12-06 |
| Reported by FDA | 2019-12-18 |
| Distributed | CA, FL, IA, KY, NE, OH, PA, SC, TN, UT, WA |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10790986000657 |
| Lot numbers | 190123-59 |
Product
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Reason for recall
Failed to meet USP minimum average value for knot pull (tensile) strength.
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-0655-2020. 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.