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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics Hoffman LRF Telescopic Strut

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  Class 2 Device Recall Stryker Orthopaedics Hoffman LRF Telescopic Strut see related information
Date Initiated by Firm July 03, 2012
Date Posted November 08, 2012
Recall Status1 Terminated 3 on April 17, 2014
Recall Number Z-0266-2013
Recall Event ID 63273
510(K)Number K113327  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product Hoffman LRF Telescopic Strut Short
Stryker
Stryker Trauma AG
CH-2545 Seizach
Distributed in the USA by
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.

The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.
Code Information K113327 Catalog No:  Telescopic Strut Extra Short Hoffman LRF Length: 4933-0-100 :100-125mm (Black) 4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) 4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) 4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red);  Lot Code: 4933-0-100 Telescopic Strut Extra Short Hoffman LRF Length 100-125mm (Black) X28937; Z04197; Z09163; Z09597; Z12135;   4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) X28961; Z04199; Z09161; Z09769; Z12012;   4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) X34352; Z04200; Z05068; Z09011; Z09598; Z10872;   4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red); X28963 ;Z04429; Z09471; Z11686
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Ms. Colleen O'Meara
201-972-2100
Manufacturer Reason
for Recall		 Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS.
FDA Determined
Cause 2		 Device Design
Action Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE FIELD REMOVAL" letter dated July 2, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Business Reply Form was included for customers to complete and return to via fax to 1-865-252-3635. Contact the firm at 1-866-626-7747 for assistance.
Quantity in Commerce 165 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KTT and Original Applicant = STRYKER CORP.
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