FDA recall Z-0655-2020

CP Medical Inc · Class II · device

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.

Distribution

USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE

Key facts

Status
Ongoing
Initiation date
2019-10-18
Report date
2019-12-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norcross, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0655-2020