Hoffman LRF Hexapod Strut recall
Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients…
Why was Hoffman LRF Hexapod Strut recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: L13687 L22247 L18236 L25182 L31085 L35845 L47079 L47736 L57503 Y00078 Y03126 Y07637 Y07634 Y11976 Y14639 Y14643 Y18430
- 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…
- Recalling firm
- Stryker GmbH
- Quantity
- 578
- Distribution
- US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.
- Recall date
- November 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)