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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 Device Recall Hoffman LRF Wire Boltsee related information
Date Initiated by FirmOctober 25, 2012
Date PostedJanuary 17, 2013
Recall Status1 Terminated 3 on December 01, 2015
Recall NumberZ-0695-2013
Recall Event ID 63863
510(K)NumberK113327 
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
ProductHoffman 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 NJ 07430
For Additional Information ContactMs. 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		Device Design
ActionStryker 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 Commerce476 units
DistributionNationwide Distribution, including the states of PA, OH, NY, CA and IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KTT
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