Stelkast Cross-over Acetabular Shell and Liner Hip recall
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in…
Why was Stelkast Cross-over Acetabular Shell and Liner Hip recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Stelkast Co
- Quantity
- 254
- Distribution
- Nationwide Distribution including the states of NV, OK and PA.
- Recall date
- April 17, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)