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Terminated

AOS Trochanteric Nail, 11mm x 20cm x 135, Product Part Number: 1038-200.

FDA Recall Z-1186-2010 · Posted 2010-03-22

Recalling FirmAdvanced Orthopaedic Solutions Inc
Recall StatusTerminated
Product CodeHSB
Date Initiated2010-01-14
Date Terminated2012-04-26
Product Quantity33

Reason for Recall

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Firm Action

The recall was initiated with the firm forwarding a recall notice with attached customer response form on January 14, 2010 to the affected consignees. The recall notice informed the consignees of the reason for recall and gave them three steps to follow to inspect the affected Short Trochanteric Nail products. Consignees were provided with product return instruction for any incorrectly bent products found during their inspection. Customers with questions are instructed to contact the firm at (310) 533-9966.

Root Cause

Process control

Distribution Pattern

Nationwide and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021008ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAILAdvanced Orthopaedic Solutions, Inc. · 2002-06-20

Official Source

View FDA Recall →

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

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