Z-1829-2011

Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile, Stryker...

Name: Z-1829-2011 Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile, Stryker...
Creator: Stryker Instruments Division of Stryker Corporation
Published: 2011-02-03
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2011-02-03 / Terminated / root cause: packaging

FDA source

Stryker Instruments Division of Stryker Corporation began a recall of Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile, Stryker Instruments, Kalamazoo, MI. The DeKompressor Percutaneous... on 2011-02-03. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1829-2011
Status: Terminated
Initiated: 2011-02-03
Posted: 2011-03-28
Terminated: 2011-06-01
Recalling firm: Stryker Corp.
Product: 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
Product code: HRX Arthroscope
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.
Root cause tag: packaging
FDA 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. Upon receipt of the product, a replacement would be issued to their account. For questions regarding this recall call 1-800-253-3210.
Quantity in commerce: 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.
Product codes and lots: Lot: 10214012.

Product code HRX

K032473Class IIDekompressor Percutaneous Discectomy ProbeStryker Instruments / cleared 2003-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)