Z-0093-2011

Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box)

Name: Z-0093-2011 Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box)
Creator: Codman & Shurtleff, Inc.
Published: 2010-07-16
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2010-07-16 / Terminated / root cause: manufacturing process

FDA source

Codman & Shurtleff, Inc. began a recall of Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396 on 2010-07-16. The reason FDA records is "Surgical Pattie x-ray stripe (radio-opaque marker) became detached". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0093-2011
Status: Terminated
Initiated: 2010-07-16
Posted: 2010-10-20
Terminated: 2012-07-09
Recalling firm: Cerenovus, Inc.
Product: Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396
Product code: HBA Neurosurgical Paddie
Reason for recall: Surgical Pattie x-ray stripe (radio-opaque marker) became detached
Root cause tag: manufacturing process
FDA 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 in commerce: 673 boxes (20 pouches of 10 patties per box)
Distribution: Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,
Product codes and lots: Lot numbers: EB515 GB501 HB489 KB431 KB431 KB529 KB529 LB412 LB436 LB437 421412 422509 423818 423819 423820

Product code HBA

K880402Class IICodman Surgical PattieCodman & Shurtleff, Inc. / cleared 1988-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)