Z-2238-2008

Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand...

Name: Z-2238-2008 Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand...
Creator: Stryker Spine
Published: 2008-06-05
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-06-05 / Terminated / root cause: manufacturing process

FDA source

Stryker Spine began a recall of Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand held device intended for medical purposes to... on 2008-06-05. The reason FDA records is "The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2238-2008
Status: Terminated
Initiated: 2008-06-05
Posted: 2008-09-19
Terminated: 2008-09-22
Recalling firm: Howmedica Osteonics Corp
Product: Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Ref Number 48500900;Non Sterile
Product code: HXX Screwdriver
Reason for recall: The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: URGENT PRODUCT RECALL letters were sent to all branches/agencies who received the product on June 5, 2008. If you have questions, contact Michelle Klein at 201-760-8256.
Quantity in commerce: 35
Distribution: The product was distributed to 13 Stryker branches/agencies.
Product codes and lots: Lot codes: 26719, 047377, 047570, 065167, 06A167, and 072689.

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)