FDA Medical Device Recalls (openFDA)
CP Medical Inc: PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
- Recall number
- Z-1872-2017
- Recalling firm
- CP Medical Inc
- Product
- PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
- Status
- Open, Classified
- Initiated
- 2017-02-02
- Posted
- not on file
- Terminated
- not on file
- Reason
- The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.
- Root cause
- Unknown/Undetermined by firm
- Action
- The affected distributors/customers were contacted directly via telephone or by e-mail on February 6-7, 2017. Those end users not contacted by CP Medical directly will be contacted by their distributor
- Quantity
- 504 boxes/12 sutures - 6,048 individual sutures
- Distribution
- AL, AZ, AR, CA, CO, CT, FL, ID, IL, IN, KY, LA, MT, NE, NJ, NM, NY, OK, OR, SC, TX, WA and South Africa
- Lot, serial or model codes
- Lot Numbers - 150323-04, 150324-04, 150520-10, 150615-01, 150616-08, 150709-01, 151229-64, 160414-69, 160510-59, 160617-52, 160824-50
- 510(k) numbers
- ["K072229"]
- 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