Z-1242-2010

PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N 75006725, QTY: (1), STERILE R, Smith & Nephew Orthopaedics...

Name: Z-1242-2010 PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N 75006725, QTY: (1), STERILE R, Smith & Nephew Orthopaedics...
Creator: Smith & Nephew Inc
Published: 2010-01-14
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2010-01-14 / Terminated / root cause: design

FDA source

Smith & Nephew Inc began a recall of PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N 75006725, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland. The device is used... on 2010-01-14. The reason FDA records is "Firm received complaints of Inclination Set Screws fracturing". 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-1242-2010
Status: Terminated
Initiated: 2010-01-14
Posted: 2010-04-07
Terminated: 2012-04-10
Recalling firm: Smith & Nephew, Inc.
Product: PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N 75006725, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland. The device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Firm received complaints of Inclination Set Screws fracturing.
Root cause tag: design
FDA root cause: Device Design
Action: All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on January 23, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 23, 2009. They were instructed to immediately quarantine the product for return to Stericycle, Inc., 2670 Executive Dr. Suite A Indianapolis, IN 46241. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-6153.
Quantity in commerce: 362 units
Distribution: Worldwide Distribution: United States, Australia, Austria, Belgium, China, Denmark, France, Germany, Greece, Great Britain, Italy, Netherlands, Poland, Portugal, Spain, Sweden and Switzerland.
Product codes and lots: All lots.

Product code KWS

K063578Class IIPromos Modular Shoulder SystemPlus Orthopedics AG / cleared 2007-03-02

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)