Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas France.,Distributed by Howmedica Osteonics Corp. 325 Corporate Drive, Mahway, NJ 07430
FDA Recall Z-1239-2007 · Posted 2007-09-21
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Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeNKB
Date Initiated2007-07-10
Date Terminated2007-12-11
Product Quantity1,300 in US, 123 in Italy
Reason for Recall
Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod
Firm Action
Product recall letters were sent to branches/agencies and hospitals on 7/10/2007 requesting product return.
Root Cause
Other
Distribution Pattern
Worldwide- USA: Distributed to Stryker Branches/Agencies in MA, NY, NC. IN, MI, OK, TX,CO, AZ, WI, KS, CA, OR and hospitals in NC IN, MI, MO. KS, TZ, AZ, CA. OR and WA and Country of Italy
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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