Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
This recall has been terminated (originally issued October 28, 2009).
- Company
- Ortho Development Corporation
- Recall Initiated
- April 29, 2009
- Posted
- October 28, 2009
- Terminated
- May 25, 2010
- Recall Number
- Z-0086-2010
- Quantity
- 23
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.
Distribution
AZ, CA, FL, MA, MI. No military, government or foreign distribution.
Lot / Code Info
Part 133-2846, Lots 3370, 3534, 3620, 3731 Part 133-2847, Lots 3492, 3535 Part 133-2848, Lot 3509 Part 133-2851, Lot 3433 Part 133-2852, Lot 3661
Root Cause
Device Design
Action Taken
Ortho sent a Field notification Memo dated 4/2/2009 to agents and distributors, giving them pre-implant examination guidelines. Decision to recall non-implanted units was made on 4/29/2009 and this was communicated by telephone to distributors.
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