Data Foundry

Medical device recalls 2013

Stelkast Cross-over Acetabular Shell and Liner Hip System — Class II medical device recall Z-1066-2013

Terminated recall by Stelkast Co, reported 2013-04-17, distributed nationwide. Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 3

Recall numberZ-1066-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStelkast Co, Mcmurray, PA, United States
Recall initiated2013-01-24
Classified2013-04-06
Reported by FDA2013-04-17
Terminated2014-10-08
DistributedNationwide (US)
Quantity254
Lot numbers28820-112612, 28821-000, 28822-101812, 28823-101812, SC3459-52, SC3460-52, SC3474-52
Model numbersSC3458-52, SC3459-52, SC3460-52, SC3474-52

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1066-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.