Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shave
FDA device recall Z-1872-2014 · posted 2014-06-25 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.
- Action taken
- Device Correction letters were sent on May 23, 2014 to all users by certified mail. Internation sites will receive notification and be responsible for contacting customers.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 1992 trays
- Distribution
- Worldwide Distribution.
- Date initiated
- 2014-05-19
- Date posted
- 2014-06-25
- Date terminated
- 2015-05-07
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SE5 ARTHROSCOPY SYTEM (K941333) | Stryker Endoscopy | 1994-11-10 |