The Recall Desk
SevereFDA (Devices)·Z-0266-2013·Announced 2012-11-14

Stryker Recalls Hoffman LRF Telescopic Struts Due to Breakage

Stryker Howmedica Osteonics Corp. is recalling 165 Hoffman LRF Telescopic Struts because three complaints reported the devices breaking during load-bearing use in patients weighing over 250 lbs.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (breakage) in a load-bearing medical device, which aligns with the rubric criteria for 'Severe' severity involving significant injury or structural defects.

Plain-English summary

Stryker Howmedica Osteonics Corp. is recalling 165 units of Hoffman LRF Telescopic Struts. These medical devices are used for bone fixation in fracture and reconstructive surgery. The recall covers specific catalog numbers and lot codes for Extra Short, Short, Medium, and Long strut lengths.

The recall was initiated after three complaints were filed reporting that the telescopic struts broke during load-bearing application. These incidents occurred in patients with a body weight greater than 250 lbs. The devices are distributed nationwide.

Healthcare providers and patients should stop using the affected devices and contact Stryker Howmedica Osteonics Corp. for instructions on replacement or return. The recall is classified as Class II by the FDA.

The recalled product

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 f
Affected units
165

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • Z04197
  • Z09163
  • Z09597
  • Z12135
  • 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

Distribution

Distributed nationwide across the United States.