PlainRecordsFDA · Medical device recall
Alphatec Spine Solanas Titanium Pedicle Screw… and 1 more product
- Date posted by the FDA
- Dec. 14, 2009
- Status
- Terminated
- Filed by
- Alphatec Spine, Inc.
- Reason
- Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
- Distribution pattern
- Nationwide distribution.
2 products in this recall
Alphatec Spine Solanas Titanium Pedicle Screw…
- Product
- Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12
- Quantity
- 163 Units
- Codes and lots
- Lot Numbers: 624239, 624240
- Recall started
- Aug. 5, 2009
- Device type
- Appliance, Fixation, Spinal Interlaminal
- Root cause (FDA)
- Process control
- What the company told customers
- Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located. If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days.
- Recall number
- Z-0502-2010
Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14
- Product
- Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14
- Quantity
- 158 units
- Codes and lots
- Lot Numbers: 624241, 624242, 625418
- Recall started
- Aug. 5, 2009
- Device type
- Appliance, Fixation, Spinal Interlaminal
- Root cause (FDA)
- Process control
- What the company told customers
- Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located. If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days.
- Recall number
- Z-0503-2010
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0502-2010, Z-0503-2010. The agency record governs; check it and the company before acting.