Recall Z-0266-2013— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-0266-2013
Creator: U.S. Food and Drug Administration
Published: 2012-07-03

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2012-07-03, terminated 2014-04-17. It names one FDA 510(k) clearance: K113327. 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.. Reason: 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..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2012-07-03
Terminated: 2014-04-17
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K113327 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEMStryker Corp.·cleared 2012-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.