Skip to content
Recall Observatory FDA recall evidence

Device product

Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr Ball Head, 28 XX-Long CoCr Ball Head, 32 Short Ball Head, 32 Medium Ball Head, 32 Long

Z-1386-2013

February 20, 2013

Class II

Product summary

Firm
Orthopedic Alliance LLC
Event
Event 64588
Status
Terminated
Classification
Class II
Quantity
26 units
Official record key
device-enforcement:Z-1386-2013

Official wording

Reason: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Code information: Part No. 194.01.28 194.02.28 194.03.28 195.01.32 195.02.32 195.03.32 188.01.28 188.02.28 188.03.28 188.04.28 188.05.28 189.01.32 189.02.32 189.03.32

Distribution pattern: Nationwide Distribution including the states of CA, MD, TX, NV, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.