Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266, Sterile, Stryker Instruments, Kalamazo
FDA device recall Z-1830-2011 · posted 2011-03-28 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Division of Stryker Corporation
- Reason for recall
- The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot number of 10214012.
- Action taken
- Stryker Instruments Division of Stryker Corporation sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 3, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their inventory for any recalled product and quarantine any affected product. If the product was further distributed, customers were asked to forward the letter and the completed Reply Form to all affected locations. Customers were to be contacted to coordinate return of the affected product. Upon receipt of the product, a replacement would be issued to their account. For questions regarding this recall call 1-800-253-3210.
- Root cause
- Other
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 44 units both products
- Distribution
- Worldwide Distribution - USA including the states of PA, NY, KS, NJ, TX, MI, OK, and FL, and the countries of Italy and Switzerland.
- Date initiated
- 2011-02-03
- Date posted
- 2011-03-28
- Date terminated
- 2011-06-01
- Location
- Kalamazoo, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE (K032473) | Stryker Instruments | 2003-11-07 |