Recall Z-0290-2019
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 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]
Codes / lots: 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
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-0290-2019
- Initiated
- August 28, 2018
- Terminated
- February 4, 2021
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Quantity
- 1355
- 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-0291-2019 Class II | Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product…The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet… | 08/28/2018Terminated |