Z-0288-2019Class II
Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF...
Stryker Corp. / initiated 2018-08-28 / Terminated
Stryker GmbH began a recall of 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... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0288-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- 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]
- Product code
- KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- 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 root cause
- Under Investigation by firm
- Action
- Urgent Product Recall notification letters dated 8/28/18 were sent to customers.
- Quantity in commerce
- 578
- Distribution
- US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.
- Product codes and lots
- Lots: L13687 L22247 L18236 L25182 L31085 L35845 L47079 L47736 L57503 Y00078 Y03126 Y07637 Y07634 Y11976 Y14639 Y14643 Y18430
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0288-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0289-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0290-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0291-2019 | Class II | Terminated | Voluntary: Firm initiated |
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