Recall Z-0291-2019
Stryker GmbH · initiated August 28, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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]
Codes / lots: 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
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.
FDA-determined cause: Under Investigation by firm
Action taken
Urgent Product Recall notification letters dated 8/28/18 were sent to customers.
Details
- Recall number
- Z-0291-2019
- Initiated
- August 28, 2018
- Terminated
- February 4, 2021
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Quantity
- 867
- Distribution
- US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.
- Recalling firm
- Stryker GmbH, Selzach
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0288-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | 08/28/2018Terminated |
| Z-0289-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | 08/28/2018Terminated |
| Z-0290-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | 08/28/2018Terminated |