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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- 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
Related recalls
Same manufacturer · Stryker Howmedica Osteonics Corp.
See all →- SevereStryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
FDA (Devices) · 2017-01-18
- ModerateStryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2016-12-28
- SevereStryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
FDA (Devices) · 2016-11-16
- HighStryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
FDA (Devices) · 2016-10-19
- HighStryker Patella Assembly Instrument Recalled for Component Disassociation Risk
FDA (Devices) · 2016-09-21
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- SevereStryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk
FDA (Devices) · 2018-11-07
- SevereStryker Recalls Hoffman LRF Telescopic Struts Due to Breakage
FDA (Devices) · 2012-11-14
- HighStryker Hoffmann LRF Transport Strut Locking Mechanism Recall
FDA (Devices) · 2023-03-08
- SevereStryker Recalls Hoffmann LRF Hexapod Struts Due to Pin Fit Defect
FDA (Devices) · 2018-11-07
- ModerateStryker Recalls 18 Hinge Coupling Units Due to Packaging Error
FDA (Devices) · 2018-05-02
- HighStryker Recalls Hoffman LRF Wire Bolts Due to Breakage During Use
FDA (Devices) · 2013-01-23