Use caution Medical device recall · FDA · Published August 28, 2018

Stryker Hoffman LRF Hexapod Strut Recall: Risk of Strut Displacement

Stryker recalls Hoffman LRF Hexapod Struts with model 4935-0-040 due to potential pin displacement causing instability. Affected units sold in specific lots; contact Stryker for remedy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0291-2019Medical device Stryker ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmStryker GmbHBohnackerweg 1 · Selzach, Switzerland

✎ GovInfoNow plain-language explainer

Stryker is recalling Hoffman LRF Hexapod Struts (model 4935-0-040) because a manufacturing defect may cause the pin to become loose, leading to loss of stability. This could result in improper treatment of fractures or other medical conditions if the device fails during use. Read more at govinfonow.com/recall/69951-stryker-hoffman-lrf-hexapod-strut-recall-risk-of-strut-displacement.

Source Summary by GovInfoNow · govinfonow.com/recall/69951-stryker-hoffman-lrf-hexapod-strut-recall-risk-of-strut-displacement · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0291-2019

Cite this page

“Stryker Hoffman LRF Hexapod Strut Recall: Risk of Strut Displacement.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69951-stryker-hoffman-lrf-hexapod-strut-recall-risk-of-strut-displacement. Based on FDA recall #Z-0291-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0291-2019%22&limit=1).

Stryker GmbH recalled the Hoffman LRF Hexapod Strut, Model Number 4935-0-040, due to a dimensional discrepancy that may cause pin displacement. The Food and Drug Administration announced this Class II recall on August 28, 2018.

How to tell if you have it

Brand: Stryker
Product: Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm
Model Number: 4935-0-040
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
Units affected: 867

The hazard

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, resulting in partial or full displacement or loss of the pin and ensuring stability of the strut cannot be guaranteed.

Context

GovInfoNow's records show Stryker GmbH has issued 20 other recalls since March 12, 2018. Recent issues include a July 1, 2026 recall for potential cracking of Hoffmann II Carbon Connecting Rods and a May 28, 2025 recall regarding wrong nail geometry for the Gamma4 Right Long Nail. Other recent recalls of similar products include an October 30, 2025 Olympus HX-400U-30 Ligating Device Recall for risk of unintentional loop fixation and a November 17, 2025 Molift 4-Point Sling Bars Recall for deformation risk during use.

How to tell if you have this one

Check for model number 4935-0-040 on the Hoffman LRF Hexapod Strut. The product was sold in specific lots listed in the recall notice, including L18239 through Y16719.

Brand
Stryker
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.

Recall number	Product, codes & lots	Quantity
Z-0288-2019	Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. 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]; Lots: L13687 L22247 L18236 L25182 L31085 L35845 L47079 L47736 L57503 Y00078 Y03126 Y07637 Y07634 Y11976 Y14639 Y14643 Y18430	578
Z-0289-2019	Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. 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]; Lots: L18237 L13688 L22248 L25187 L31271 L35846 L46782 L47078 L47196 L50180 L51361 L53108 L53489 L57504 L58108 L57506 Y00082 Y02871 Y03127 Y08559 Y08560 Y12875 Y14371 Y14640 Y14644 Y14645	832
Z-0290-2019	Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. 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]; Lots: L18238 L13689 L22249 L26333 L31075 L31035 L35849 L35850 L45970 L46580 L47080 L46577 L46781 L47195 L49918 L49816 L51362 L53106 L53487 L53823 L53488 L56830 L56831 L57502 Y00081 Y00080 Y02872 Y02873 Y03128 Y07628 Y07630 Y08561 Y08555 Y08554 Y08553 Y12876 Y14867 Y14641	1355
Z-0291-2019	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]; 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	867

Based on the official FDA remedy

What to do — step by step

Check Product Lot
Identify the lot number on the product, which is listed in the recall notice (e.g., L18239, L13690, etc.).
Contact Stryker
Reach out to Stryker for instructions on how to return or repair the device if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 7 states.

FDA distribution: “US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Colorado, Florida, Maryland, Michigan, New York, Oklahoma, Pennsylvania.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Aug 28, 2018Firm started the recall
Oct 29, 2018FDA classified it Class II
Nov 7, 2018Published in FDA’s Enforcement Report
Feb 4, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69951-stryker-hoffman-lrf-hexapod-strut-recall-risk-of-strut-displacement">Stryker Hoffman LRF Hexapod Strut Recall: Risk of Strut Displacement (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0291-2019 (August 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0291-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.