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Terminated

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

FDA Recall Z-1267-2013 · Posted 2013-05-07

Recalling FirmSymmetry Medical/SSI
Recall StatusTerminated
Product CodeDWS
Date Initiated2013-04-10
Date Terminated2014-05-12
Product Quantity524 boxes of 10

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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