Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10… recallZ-0094-2011 · 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-0094-2011
- 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
- 4407 boxes (20 pouches of 10 patties)
- 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 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
Code information (models, lots, serial numbers)
Lot numbers: EB514 FB465 GB498 GB449 HB544 HB545 KB438 KB538 KB436 KB527 LB554 LlB555 AC464 421417 421418 421419 422512 423826 423076 423827 423828 423829 423830 423075 HB499
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-0093-2011 · TerminatedCodman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396
- 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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