TI Standard Polyaxial Screw Assembly 6.5MM x 55MM recall
TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is…
Why was TI Standard Polyaxial Screw Assembly 6.5MM x 55MM recalled?
The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 634745
- Product
- TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is…
- Recalling firm
- Alphatec Spine, Inc.
- Quantity
- 11 units
- Distribution
- Nationwide Distribution including TN, WI, and FL.
- Recall date
- November 14, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)