Z-0095-2011

Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card)

Name: Z-0095-2011 Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card)
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 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 on 2010-07-16. The reason FDA records is "Surgical Pattie x-ray stripe (radio-opaque marker) may become 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-0095-2011
Status: Terminated
Initiated: 2010-07-16
Posted: 2010-10-20
Terminated: 2012-07-09
Recalling firm: Cerenovus, 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
Product code: HBA Neurosurgical Paddie
Reason for recall: Surgical Pattie x-ray stripe (radio-opaque marker) may become 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: 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,
Product codes and lots: 09A0061 09B0310 09C0708 09C0709 09C0709 09E1139 09F1516 09F1517 09G1830 09G1830 09H2170 09J2622 09H2170 09J2622 09L3080 10B0196 10B0317 10C0442 10B0318 10C0442 Lot numbers: 8L2688

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)