Z-0763-2010

Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile; Manufactured by: Stryker Spine SAS, Cestas...

Name: Z-0763-2010 Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile; Manufactured by: Stryker Spine SAS, Cestas...
Creator: Stryker Spine
Published: 2009-10-12
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-10-12 / Terminated / root cause: manufacturing process

FDA source

Stryker Spine began a recall of Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile; Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2... on 2009-10-12. The reason FDA records is "The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the...". 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-0763-2010
Status: Terminated
Initiated: 2009-10-12
Posted: 2010-04-12
Terminated: 2012-09-06
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile; Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ. The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An "Urgent Product Recall" letter was sent to Stryker Branches/Agencies on October 12, 2009 and to surgeons who have used the device on October 26, 2009. The recall letter described the affected products, issue and potential hazards. Consignees were instructed to examine their inventory and hospital locations for the affected products and return to Stryker Spine as indicated in the recall letter. Customers were also instructed to complete the enclosed Customer Response form and fax to 1-201-760-8370. Direct questions about the recall to Stryker Spine by calling 1-201-760-8206.
Quantity in commerce: 983
Distribution: Worldwide Distribution.
Product codes and lots: Ref # 48511905B, all lots.

Product code KWQ

K062310Class IIReflex Hybrid Acp SystemStryker Spine / cleared 2006-08-18

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)