Z-1186-03

Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system

Name: Z-1186-03 Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system
Creator: Wright Medical Technology Inc
Published: 2003-08-18
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2003-08-18 / Terminated

FDA source

Wright Medical Technology Inc began a recall of Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system on 2003-08-18. The reason FDA records is "Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1186-03
Status: Terminated
Initiated: 2003-08-18
Posted: 2003-08-28
Terminated: 2004-01-29
Recalling firm: Wright Medical Technology Inc
Product: Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.
Product code: MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Reason for recall: Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation.
FDA root cause: Other
Action: Distributors returned thier stock after May 8, 2003
Quantity in commerce: 133 units
Distribution: nationwide
Product codes and lots: Part No. Lot Serial No. 73003258 070A122950 71002846 101A147607 72003252 101A147579 71002846 01214750 73003258 020A116075 73003258 101A147616 71002846 101A147609 71002846 01214749 72003252 01214581 72003252 01215268 73003258 101A147617 73003258 01214576 74003664 101A147618 72003252 101A147580 71002846 048A080430 72003252 0124580 71002846 01214751 74003664 061A136523 72003252 119A112057 73003258 01214575 71002846 031A139399 72003252 101A147577 72003252 01214582 72003252 101A147578 71002846 039A100609 72003252 081A145884

Product code MRA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)