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U.S. Department of Health and Human Services

Class 2 Device Recall Hoffman LRF Wire Bolt

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 Class 2 Recall
Hoffman LRF Wire Bolt
see related information
Date Posted January 17, 2013
Recall Status1 Open
Recall Number Z-0695-2013
Recall Event ID 63863
Premarket Notification
510(K) Number
K113327 
Product Classification Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Product Code KTT
Product Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Code Information Catalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.
FDA Determined
Cause 2
DESIGN: Device Design
Action Stryker sent "Urgent Medical Device Removal" notification letters and acknowledgement forms dated 10/25/2012 via Fed Ex to Branches/Agencies with return receipt. Stryker sent notification letters/acknowledgement forms dated 10/26/202 via Fed Ex to Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letters described the device issue and provided recommended actions. Questions were directed to Stryker Customer Service.
Quantity in Commerce 476 units
Distribution Nationwide Distribution, including the states of PA, OH, NY, CA and IL.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = STRYKER CORP.
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