CLASS II Device recall · Reported 15 May 2013 · FDA Enforcement Report

Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" recalled

Symmetry Medical/SSI is recalling Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" long, 3" wide, 1/2" deep, distributed in 11 states. The recall was initiated on 10 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160
Quantity recalled524 boxes of 10

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1267-2013
FDA event ID
64962
Recalling firm
Symmetry Medical/SSI, Antioch, TN
Classification
Class II
Status
Terminated
Recall initiated
10 Apr 2013
FDA classified
7 May 2013
Reported
15 May 2013
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Device Malfunction

Timeline

10 Apr 2013Recall initiated by company
7 May 2013Classified by FDA+27 days
15 May 2013Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK

CaliforniaColoradoFloridaIllinoisMassachusettsMichiganMississippiOhioPennsylvaniaTennesseeTexas

Questions about this recall

Why was it recalled?

There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.

Which lots are affected?

244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160

Where was it sold?

Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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