Z-0960-2009

PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile Instrument for...

Name: Z-0960-2009 PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile Instrument for...
Creator: Smith & Nephew Inc
Published: 2008-11-21
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2008-11-21 / Terminated

FDA source

Smith & Nephew Inc began a recall of PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer... on 2008-11-21. The reason FDA records is "The product was breaking during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0960-2009
Status: Terminated
Initiated: 2008-11-21
Posted: 2009-02-03
Terminated: 2012-11-27
Recalling firm: Smith & Nephew, Inc.
Product: PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: The product was breaking during use.
FDA root cause: Other
Action: All affected Smith & Nephew International Distributors were notified via email on 11/21/2008. They were instructed to immediately notify their accounts concerning the recall. Contact Smith & Nephew Inc at 901-399-6771 for assistance.
Quantity in commerce: 159 units
Distribution: Germany, France, Italy Austria, Switzerland, Belgium, United Kingdom, Greece, Australia, South Africa, Spain, and Cypress
Product codes and lots: Lot numbers: A1, A1B1107, A2, A3B1107, A3, A3B1107, A4, A4/I, A51767, A51767B706, B57815, B58460, B60400, and B62141

Product code KWS

K081016Class IISmith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc. / cleared 2008-09-05

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)