FDAClass IINovember 7, 2018

Hoffman LRF Hexapod Strut recall

Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric…

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: 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

Product
Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric…
Recalling firm
Stryker GmbH
Quantity
867
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)
Open FDA enforcement record Latest recalls