Stryker Hoffmann LRF Transport Strut Locking Mechanism Recall
Stryker is recalling Hoffmann LRF Transport Strut devices due to oversized thread pitch that prevents the distal ring fixation from locking, affecting 488 units nationwide.
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: FDA Class II medical device recall for a functional defect (oversized thread pitch) that prevents proper locking of an orthopedic fixation device. No injuries or hospitalizations reported; the defect creates a risk of harm through device malfunction but no adverse events have been documented.
Plain-English summary
Stryker is recalling specific lots of the Hoffmann LRF Bone Transport Strut (Model 4933-0-400), an orthopedic external fixation device intended to keep bone fragments in proper position during healing. The recalled devices have an oversized thread pitch at the distal end of the threaded rod, which prevents the distal ring fixation from locking between 0–50mm of the threaded rod.
This defect affects 488 units that were distributed nationwide. The affected devices are identified by specific serial numbers listed in the recall notice. Because the fixation ring cannot lock properly, the device cannot perform its intended function of maintaining correct positioning of bone fragments during the healing process.
Patients and healthcare providers with affected serial numbers should contact Stryker for guidance regarding affected devices.
The recalled product
- Product
- stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
- Manufacturer
- Stryker GmbH
- Hazard
- device-malfunction
- locking-failure
- fixation-failure
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 (20)
- Serial numbers: D32158
- D32160
- D32161
- D32162
- D32163
- D32164
- D34343
- D34344
- D40690
- D41629
- D41630
- D41631
- D44713
- G16331
- G16332
- G16333
- G26278
- G29759
- G29760
- G32730
Distribution
Distributed nationwide across the United States.
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