FDA Medical Device Recalls (openFDA)
Codman & Shurtleff, Inc.: Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403
- Recall number
- Z-0095-2011
- Recalling firm
- Codman & Shurtleff, Inc.
- Product
- Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403
- Status
- Terminated
- Initiated
- 2010-07-16
- Posted
- 2010-10-20
- Terminated
- 2012-07-09
- Reason
- Surgical Pattie x-ray stripe (radio-opaque marker) may become detached
- Root cause
- Process control
- Action
- Codman notified customers by letter dated 7/16/10 issued July 23 through July 26, 2010 via Fed'x overnight advising users that the x-ray marker on Codman Surgical Patties may become detached. Customers are instructed to return product from affected lots. An error in the original letter was discovered and a corrected letter dated July 28, 2010 issued. If there are any questions, please contact Codman at (800) 225-0460.
- Quantity
- 229 boxes (100 cards/10 patties each card)
- Distribution
- Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,
- Lot, serial or model codes
- 09A0061 09B0310 09C0708 09C0709 09C0709 09E1139 09F1516 09F1517 09G1830 09G1830 09H2170 09J2622 09H2170 09J2622 09L3080 10B0196 10B0317 10C0442 10B0318 10C0442 Lot numbers: 8L2688
- 510(k) numbers
- ["K880402"]
- PMA numbers
- not on file
- Product code
- HBA
- Firm FEI
- 3002947440
- Firm city
- Raynham
- Firm state
- MA
- 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