PROMOS Inclination set, SIZE 24mm, REF 42 184, S&N 75006724, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rot
FDA device recall Z-1241-2010 · posted 2010-04-07 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Firm received complaints of Inclination Set Screws fracturing.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 366 units
- Distribution
- Worldwide Distribution: United States, Australia, Austria, Belgium, China, Denmark, France, Germany, Greece, Great Britain, Italy, Netherlands, Poland, Portugal, Spain, Sweden and Switzerland.
- Date initiated
- 2010-01-14
- Date posted
- 2010-04-07
- Date terminated
- 2012-04-10
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROMOS MODULAR SHOULDER SYSTEM (K063578) | Plus Orthopedics AG | 2007-03-02 |