CLASS II Device recall · Reported 7 Nov 2018 · FDA Enforcement Report

Hoffman LRF Hexapod Strut, Extra Short recalled by Stryker

Stryker is recalling Hoffman LRF Hexapod Strut, Extra Short, distributed nationwide in the US. The recall was initiated on 28 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: L18239 L13690 L22250 L26334 L31272 L35847 L35848 L46136 L46137 L46495 L46497 L50179 L51363 L53107 L53490 L59090 Y02173 Y07632 Y08556 Y08558 Y08557 Y14369 Y14370 Y16719 Y14646 Y14642

Quantity recalled867

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0291-2019
FDA event ID: 81087
Recalling firm: Stryker, Selzach, N/A
Classification: Class II
Status: Terminated
Recall initiated: 28 Aug 2018
FDA classified: 29 Oct 2018
Reported: 7 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

28 Aug 2018	Recall initiated by company
29 Oct 2018	Classified by FDA	+62 days
7 Nov 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction Pseudoarthrosis or non-union of long bones Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction Correction of bony or soft tissue deformity Correction of segmental bony or soft tissue defects Joint arthrodesis Management of communicated intra-articular fractures of the distal radius Bone transport The Hoffmann LRF System is indicated in adults for: Osteotomy Revision procedure where other treatments or devices have been unsuccessful Bone reconstruction procedures Fusions and replantations of the foot Charcot foot reconstruction Lisfranc dislocations The typical LRF construct features two or more rings bridged by three to four telescopic struts with multiplanar, ball jointed fixation bolts. Once applied, the LRF can be unlocked for gross frame adjustment and fracture reduction. The LRF can be finely adjusted to aid in limb alignment and definitively locked to hold compression and reduction. If deemed appropriate, the LRF Telescopic Struts can provide up to 5mm of controlled dynamization. Original Statement OP-Tech H-ST-1_Rev2_HoffmannLRF_OpTech_2016-10690]

Where it was distributed

US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.

Nationwide Colorado Florida Maryland Michigan New York Oklahoma Pennsylvania

Questions about this recall

Is Hoffman LRF Hexapod Strut, Extra Short recalled?

Yes. Stryker recalled Hoffman LRF Hexapod Strut, Extra Short on 28 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0291-2019.

Why was it recalled?

Which lots are affected?

Lots: L18239 L13690 L22250 L26334 L31272 L35847 L35848 L46136 L46137 L46495 L46497 L50179 L51363 L53107 L53490 L59090 Y02173 Y07632 Y08556 Y08558 Y08557 Y14369 Y14370 Y16719 Y14646 Y14642

Where was it sold?

US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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