Recall Z-1829-2011 ยท HRX Arthroscope
Stryker Instruments Division of Stryker Corporation
Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile, Stryker Instruments, Kalamazoo, MI. The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine
| Date | Mar 28, 2011 (initiated Feb 3, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032473 | DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE Stryker Instruments, Nov 7, 2003 |