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Recall Observatory FDA recall evidence

Device product

Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.

Z-0582-2014

September 30, 2013

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 66909
Status
Terminated
Classification
Class II
Quantity
1,690 units
Official record key
device-enforcement:Z-0582-2014

Official wording

Reason: Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.

Code information: Catalog number 12350-013 all lot codes

Distribution pattern: USA Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.