Z-0809-04

RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas

Name: Z-0809-04 RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas
Creator: Centerpulse Orthopedics, Inc
Published: 2003-09-30
License: https://open.fda.gov/license/

Centerpulse Orthopedics, Inc. / initiated 2003-09-30 / Terminated

FDA source

Centerpulse Orthopedics, Inc began a recall of RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas on 2003-09-30. The reason FDA records is "Compalints of acetabular shell disassociating with the bone". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0809-04
Status: Terminated
Initiated: 2003-09-30
Posted: 2004-07-20
Terminated: 2004-11-04
Recalling firm: Centerpulse Orthopedics, Inc.
Product: RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Compalints of acetabular shell disassociating with the bone.
FDA root cause: Other
Action: The firm called and issued letters on September 30, 2003 informing physicians of a complaint received. The letter requested that the physicians discontinue use of the device until and investigation could be conducted. On 03/8/2004 the firm issued a letter to Zimmer distributors to return all inventory.
Quantity in commerce: 145 units
Distribution: Physicians in the following areas: CA, Washington D.C., MD, LA, ID, and WA
Product codes and lots: Lot numbers: 1548942, 1548943, 1548944, 1548947, 1548948, 1548949, 1548950, 1553246, 1553248, 1553251, 1553252, 1553254, 1553259, 1553261, 1553262, 1553265, 1553266, 1553268, and 1553269

Product code LZO

K022985Class IIAscendent Acetabular SystemSulzer Orthopedics, Inc. / cleared 2002-12-05

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)