The Recall Desk
HighFDA (Devices)·Z-2160-2017·Announced 2017-05-31

Stryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk

Stryker is recalling Hoffmann LRF Safety Clips because they may loosen from the Quick Release mechanism on Transport Struts.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect (loosening) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Stryker Howmedica Osteonics Corp. is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clips, specifically the Bone Transport Strut model. The recall involves 437 units distributed nationwide in California, Florida, Maryland, and Vermont.

The recall is being issued because there is a potential for the safety clips to loosen from their intended position on the Quick Release mechanism of the Transport Struts. These devices are intended for the fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.

Patients and healthcare providers should contact Stryker for further instructions regarding the affected devices.

The recalled product

Product
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in
Affected units
437

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 (4)

  • Lot Numbers: J49236
  • V07241
  • V30655
  • V47575 and V49404

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically: