Z-1267-2013Class II

Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep...

Name: Z-1267-2013 Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep...
Creator: Symmetry Medical/SSI
Published: 2013-04-10
License: https://open.fda.gov/license/

Symmetry Surgical GmbH / initiated 2013-04-10 / Terminated

FDA source

Symmetry Medical/SSI began a recall of Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor on 2013-04-10. FDA classified it as Class II and gives the reason as "There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1267-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-10
Posted: 2013-05-07
Terminated: 2014-05-12
Recalling firm: Symmetry Surgical GmbH
Product: Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor
Product code: DWS Instruments, Surgical, Cardiovascular
Reason for recall: There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.
FDA root cause: Under Investigation by firm
Action: Symmetry Surgical sent an Urgent Medical Device Recall letter dated April 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have any of the affected product. If so, customers were instructed to discontinue use of the product immediately and promplty call 800-251-3000 for a return material authorization (RMA) number and to identify if they would like credit or an alternative product. Customers were asked to fill out the attached Recall Response Form and fax the completed form to 615-964-5567. Customers with questions were instructed to call 615-964-5515. For questions regarding this recall call 615-964-5515.
Quantity in commerce: 524 boxes of 10
Distribution: Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK
Product codes and lots: 244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1267-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1267-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07

Product code DWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)