Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551, Electrosurgical Suction Tip, Stryker Endoscopy, San J
FDA device recall Z-0574-2008 · posted 2008-03-05 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.
- Action taken
- Stryker notified their sales representatives by phone. Stryker sent all consignees a Product Advisory Notice dated November 19, 2007, and verbally notified them of the recall via telephone. A response form with return postage was sent with the notice. The letter requested the hospitals to quarantine and return the product to Stryker.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 8 boxes of 6 units (48 total)
- Distribution
- Nationwide Distribution.
- Date initiated
- 2007-11-16
- Date posted
- 2008-03-05
- Date terminated
- 2008-03-26
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER STILETTO ELECTROSURGICAL PROBE (K052141) | Stryker Endoscopy | 2005-10-06 |