Device product
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Z-0655-2020
Product summary
- Firm
- CP Medical Inc
- Event
- Event 84178
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 174 boxes 12 per box (plus 36 samples) - total of 2124 sutures
- Official record key
device-enforcement:Z-0655-2020
Official wording
Reason: Failed to meet USP minimum average value for knot pull (tensile) strength.
Code information: Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019
Distribution pattern: USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
Derived failure modes
-
Unknown
Failed to meet USP minimum average value for knot pull (tensile) strength.