FDAFDA · Food and drugs·Recall number Z-0266-2013
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.
Published November 14, 2012 · Recall initiated: July 3, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- Nationwide Distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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