Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1066-2013 — 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.

U.S. FDA — Device Enforcement · United States · 2013-01-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1066-2013
Date of alert: 2013-01-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stelkast Co
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1066-2013 — 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.

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