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.
- Company
- Stryker Spine
- Recall Initiated
- October 12, 2009
- Posted
- April 12, 2010
- Terminated
- September 6, 2012
- Recall Number
- Z-0762-2010
- Quantity
- 1,791
- Firm Location
- Allendale, NJ
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.
Distribution
Worldwide Distribution.
Lot / Code Info
Ref # 48511905; all lots.
Root 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.