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OmniLife Science Recall 88890

Description: OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.

OmniLife Science Recall 88890 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-0237-2022
Event ID88890
Event DescriptionOMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
Product TypeDevices
DistributionUS Distribution to states of: Colorado and Virginia.
Quantity7
Recall ReasonThe device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
Device Classification20211124
Device Code InfoUDI 00841690102496 Lot 38933
Center Classification Date20211116
Recall Initiation Date20211001
Recalling FirmOmniLife Science
Initial Notification E-Mail
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