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Terminated

DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.

FDA Recall Z-1071-2010 · Posted 2010-03-11

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2009-12-09
Date Terminated2010-05-20
Product Quantity194 units

Reason for Recall

Custom surgical kits contain Stryker CBCII Blood Conservation Kit which may lack sterility

Firm Action

DeRoyal initiated its recall by visit on 12/09/2009 and followed by letter dated 12/18/2009

Root Cause

Nonconforming Material/Component

Distribution Pattern

LA & MS

Official Source

View FDA Recall →

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

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