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Terminated

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.

FDA Recall Z-1066-2013 · Posted 2013-04-07

Recalling FirmStelkast Co
Recall StatusTerminated
Product CodeOQG
Date Initiated2013-01-24
Date Terminated2014-10-08
Product Quantity254

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.

Firm Action

The firm initiated their recall of this product on January 24, 2013 by notifying their consignees by telephone informing them of the recall.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution including the states of NV, OK and PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122773CROSS-OVER ACETABULAR SHELL & LINERStelkast Company · 2012-10-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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