Z-1066-2013Class II

Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and...

Name: Z-1066-2013 Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and...
Creator: Stelkast Co
Published: 2013-01-24
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2013-01-24 / Terminated / root cause: design

FDA source

Stelkast Co began a recall of 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... on 2013-01-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1066-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-24
Posted: 2013-04-07
Terminated: 2014-10-08
Recalling firm: Globus Medical, Inc.
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.
Product code: OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm initiated their recall of this product on January 24, 2013 by notifying their consignees by telephone informing them of the recall.
Quantity in commerce: 254
Distribution: Nationwide Distribution including the states of NV, OK and PA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1066-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1066-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-06

Product code OQG

K122773Class IICross-Over Acetabular Shell & LinerStelkast Company / cleared 2012-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)