Reported Nov 14, 2012 · Terminated
Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica…
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Drive · Mahwah, NJ · 07430
Is this the product you have?
- 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.
- Lot codes and dates
22 of 22 products
Products covered by this recall # Product as published 1 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) 2 Lot Code: 4933-0-100 Telescopic Strut Extra Short Hoffman LRF Length 100-125mm (Black) X28937 3 Z04197 4 Z09163 5 Z09597 6 Z12135 7 4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) X28961 8 Z04199 9 Z09161 10 Z09769 11 Z12012 12 4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) X34352 13 Z04200 14 Z05068 15 Z09011 16 Z09598 17 Z10872 18 4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red) 19 X28963 20 Z04429 - Amount recalled
- 165 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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