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
FDA Recall Z-2238-2008 · Posted 2008-09-19
Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeHXX
Date Initiated2008-06-05
Date Terminated2008-09-22
Product Quantity35
Reason for Recall
The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw.
Firm 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.
Root Cause
Process control
Distribution Pattern
The product was distributed to 13 Stryker branches/agencies.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.