Recall Z-1066-2013— Stelkast Co
Class II · Terminated
Class II FDA medical device recall by Stelkast Co, initiated 2013-01-24, terminated 2014-10-08. It names one FDA 510(k) clearance: K122773. 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.. Reason: 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..
- Recalling firm
- Stelkast Co
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-24
- Terminated
- 2014-10-08
- Firm location
- Mcmurray, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.