FDA Medical Device Recalls (openFDA)
CP Medical Inc: Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
- Recall number
- Z-0655-2020
- Recalling firm
- CP Medical Inc
- Product
- Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
- Status
- Open, Classified
- Initiated
- 2019-10-18
- Posted
- not on file
- Terminated
- not on file
- Reason
- Failed to meet USP minimum average value for knot pull (tensile) strength.
- Root cause
- Under Investigation by firm
- Action
- Affected customers and distributors were contacted via email on October 18, 2019 and a follow-up certified letter was sent on October 22, 2019. Those end users not contacted by CP Medical directly will be contacted by their distributor. Please contact 470-273-6049 for recall information.
- Quantity
- 174 boxes 12 per box (plus 36 samples) - total of 2124 sutures
- Distribution
- USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
- Lot, serial or model codes
- Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019
- 510(k) numbers
- ["K002190"]
- PMA numbers
- not on file
- Product code
- GAM
- Firm FEI
- 3012164473
- Firm city
- Norcross
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28