Recall Z-0762-2010
Stryker Spine · initiated October 12, 2009
Product
Stryker Reflex Hybrid Screw Extractor; Not Sterile: Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the USA 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.
Codes / lots: Ref # 48511905; all lots.
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.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0762-2010
- Initiated
- October 12, 2009
- Posted by FDA
- April 12, 2010
- Terminated
- September 6, 2012
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Quantity
- 1,791
- Distribution
- Worldwide Distribution.
- Recalling firm
- Stryker Spine, Allendale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0763-2010 | Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile; Manufactured by: Stryker…The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw… | 10/12/2009Terminated |