Agency classClass IIOur severity:High FDA (Devices)·Z-1191-2023·Announced 2023-03-08

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.

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: 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
Category: Medical Device — Orthopedic / Fixation Device
Hazard: device-malfunction
locking-failure
fixation-failure
Affected units: 488

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.

Same manufacturer · Stryker GmbH

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