Z-0266-2013Class II

Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by...

Name: Z-0266-2013 Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2012-07-03
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-07-03 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 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... on 2012-07-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0266-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-03
Posted: 2012-11-08
Terminated: 2014-04-17
Recalling firm: Howmedica Osteonics Corp
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.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0266-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0266-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-08

Product code KTT

K113327Class IIHoffmann Lrf (Limb Reconstruction Frame) SystemStryker Corp. / cleared 2012-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)