FDA Device recall Z-0655-2020
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm)
- FDA Device
- Class II
- ongoing
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm) by Cp Medical, citing failed to meet USP minimum average value for knot pull (tensile) strength.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0655-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-10-18 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cp Medical |
| Distribution | CA, FL, IA, KY, NE, OH, PA, SC, TN, UT, WA |
Product
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Reason
Failed to meet USP minimum average value for knot pull (tensile) strength.
Identifiers
| code_info | Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0655-2020%22
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