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Recall Observatory FDA recall evidence

Device product

Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S

Z-2398-2018

April 27, 2018

Class II

Product summary

Firm
Stryker GmbH
Event
Event 80131
Status
Terminated
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-2398-2018

Official wording

Reason: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.

Code information: GTIN 04546540200402; Lot code: K08327D

Distribution pattern: The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification