OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed
This recall has been terminated (originally issued May 18, 2018).
- Company
- Omnilife Science Inc.
- Recall Initiated
- May 18, 2018
- Terminated
- January 28, 2019
- Recall Number
- Z-2540-2018
- Quantity
- 16 units
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The Internal packaging, the pouch and patient labels are improperly labeled.
Distribution
US Nationwide Distribution - in the states of AZ, CA, CO, IL, FL & MA
Lot / Code Info
Lot Numbers - 29147, 29148 & 29778
Root Cause
Employee error
Action Taken
On May 18, 2108, all US Agents holding the affected inventory were notified via telephone. On May 23, 2018, OMNILife Science, Inc. issued URGENT MEDICAL DEVICE NOTICES to their customers advising them that the product is being recalled, should be quarantined and returned for repackaging. For questions call 774-226-1847 or 800-448-6664.
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