FDA Recall
Terminated
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
Recall: Z-2238-2008
·
Initiated June 5, 2008
Recall
- Recall Number
- Z-2238-2008
- Event Number
- 48699
- Firm
- Stryker Spine
- FEI Number
- 3004024955
- Product Code
- HXX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 5, 2008
- Posted
- September 19, 2008
- Terminated
- September 22, 2008
- Address
- 2 Pearl Ct, Allendale, NJ, 07401-1611
Description
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
Reason
The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw.
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.
Distribution
The product was distributed to 13 Stryker branches/agencies.
Quantity
35