Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand held devic
FDA device recall Z-2238-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw.
- Action taken
- 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
- Status
- Terminated
- Product code
- HXX
- Quantity affected
- 35
- Distribution
- The product was distributed to 13 Stryker branches/agencies.
- Date initiated
- 2008-06-05
- Date posted
- 2008-09-19
- Date terminated
- 2008-09-22
- Location
- Allendale, NJ
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