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Recall Observatory FDA recall evidence

Device product

PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.

Z-1249-2018

November 09, 2017

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 79418
Status
Terminated
Classification
Class II
Quantity
12
Official record key
device-enforcement:Z-1249-2018

Official wording

Reason: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Code information: Lot Number: 17277012 UDI: (01)4546540907035

Distribution pattern: Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bioburden levels were found
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility