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Terminated

GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical

FDA Recall Z-1692-2013 · Posted 2013-07-11

Recall StatusTerminated
Product CodeLRO
Date Initiated2013-05-30
Date Terminated2013-07-12
Product Quantity87 units

Reason for Recall

DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.

Firm Action

DeRoyal sent an Urgent: Voluntary Product Recall letter dated May 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, remove any affected product from their inventory, open its package to prevent use, and dispose in a standard trash receptacle. Customers were asked to complete the enclosed notice of destruction form and return it to DeRoyal by faxing it to 865-362-3716 or emailing it to [email protected]. For question call 865-362-1034 or contact your DeRoyal representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

USA Nationwide Distribution in the state of PA

Official Source

View FDA Recall →

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

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