FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland. The device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis.
- Recall number
- Z-1239-2010
- Recalling firm
- Smith & Nephew Inc
- Product
- PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland. The device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis.
- Status
- Terminated
- Initiated
- 2010-01-14
- Posted
- 2010-04-07
- Terminated
- 2012-04-10
- Reason
- Firm received complaints of Inclination Set Screws fracturing.
- 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
- 1,597 units
- Distribution
- Worldwide Distribution: United States, Australia, Austria, Belgium, China, Denmark, France, Germany, Greece, Great Britain, Italy, Netherlands, Poland, Portugal, Spain, Sweden and Switzerland.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K063578"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28