Recall Z-1872-2014 ยท HRX Arthroscope
Stryker Endoscopy
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
| Date | Jun 25, 2014 (initiated May 19, 2014) |
| Status | Terminated |
| Reason | STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 1992 trays |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941333 | SE5 ARTHROSCOPY SYTEM Stryker Endoscopy, Nov 10, 1994 |