Z-2241-2014 Class II Terminated
FDA device recall Z-2241-2014 was initiated by Omnilife Science Inc. on May 9, 2014 and is designated Class II. Reason for recall: Staining on hip implant. The recall status is terminated (terminated August 19, 2014). Affected quantity: 13 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2014
- Initiation Date
- May 9, 2014
- Termination Date
- August 19, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 devices
Product Description
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
Reason for Recall
Staining on hip implant.
Distribution Pattern
US: CA, OK, VA, FL, MA, NY, TX
Code Information
Lot: 17284