Recall Z-1066-2013
Stelkast Co · initiated January 24, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
Codes / lots: Part Numbers SC3458-52, lot number 28820-112612; SC3474-52, lot number 28822-101812; SC3459-52, lot number 28823-101812; and SC3460-52, lot number 28821-000.
Reason for recall
Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.
FDA-determined cause: Device Design
Action taken
The firm initiated their recall of this product on January 24, 2013 by notifying their consignees by telephone informing them of the recall.
Details
- Recall number
- Z-1066-2013
- Initiated
- January 24, 2013
- Posted by FDA
- April 7, 2013
- Terminated
- October 8, 2014
- Product code
- OQG – Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- Quantity
- 254
- Distribution
- Nationwide Distribution including the states of NV, OK and PA.
- Recalling firm
- Stelkast Co, Mcmurray, PA