Codman 5/16" Round Surgical Patties recallZ-0093-2011 · Codman & Shurtleff, Inc. · initiated Jul 16, 2010
Terminated All recalls posted in October 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Codman & Shurtleff, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Surgical Pattie x-ray stripe (radio-opaque marker) became detached
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0093-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 16, 2010
- Posted by the FDA
- Oct 20, 2010
- Recalling firm
- Codman & Shurtleff, Inc.
- Quantity
- 673 boxes (20 pouches of 10 patties per box)
- Product code
- HBA
- FDA submissions
- K880402
- Distribution
- Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,
Product description
Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396
Code information (models, lots, serial numbers)
Lot numbers: EB515 GB501 HB489 KB431 KB431 KB529 KB529 LB412 LB436 LB437 421412 422509 423818 423819 423820
Other devices under the same FDA submission
54 devices cleared under K880402 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CODMAN® 801400Integra Lifesciences Production Corporation · Neurosurgical paddie2 recalls9 reports
- CODMAN® 801407Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall6 reports
- CODMAN® 801451Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall5 reports
- CODMAN® 801404Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall4 reports
- CODMAN® 801403Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 reports
- CODMAN® 801406Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 reports
- CODMAN® 801408Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 reports
- CODMAN 80-1407Cerenovus, Inc. · NEUROSURGICAL PADDIE1 recall2 reports
- CODMAN® 801399Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall1 report
- CODMAN® 801401Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall1 report
- CODMAN® 801402Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall1 report
- CODMAN® 801454Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 56279).
- Z-0094-2011 · TerminatedCodman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
- Z-0095-2011 · TerminatedSurgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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