STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression
FDA device recall Z-0840-2013 · posted 2013-02-20 · Terminated
Recall details
- Recalling firm
- Stryker Sustainability Solutions
- Reason for recall
- Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.
- Action taken
- Stryker Sustainability Solutions sent a Urgent Medical Device Removal Notification letter dated September 5, 2012, to all affected customers. The letter identified the product, problem and the action to be taken by the customer. The firm notified that affected AC Power Adaptors would be replaced with improved Adaptors. Any affected lots would be removed and shipped back to Stryker Sustainability Solutions for final disposition. Customers were instructed to fill out the attached Recall Effectiveness Form even if no affected product was found and fax to Stryker Sustainability Solutions at (480) 809-4957
- Root cause
- Process control
- Status
- Terminated
- Product code
- JOW
- Quantity affected
- 1,311
- Distribution
- Distributed in Arizona and New Jersey.
- Date initiated
- 2012-08-30
- Date posted
- 2013-02-20
- Date terminated
- 2014-09-30
- Location
- Tempe, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESTEP DVY SYSTEM, MODEL RSP-101 (K090308) | Stortford Medical, LLC | 2009-05-01 |