Device product

Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA

Z-2241-2014

May 09, 2014

Class II

Product summary

Firm: Omnilife Science Inc.
Event: Event 68527
Status: Terminated
Classification: Class II
Quantity: 13 devices
Official record key: device-enforcement:Z-2241-2014

Official wording

Reason: Staining on hip implant.

Code information: Lot: 17284

Distribution pattern: US: CA, OK, VA, FL, MA, NY, TX

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Staining on hip implant.