Cervical Spine Locking Plate recall
Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm…
Why was Cervical Spine Locking Plate recalled?
DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a single lot of 450.136 screws (4mm Cancellous Self Tapping Screw, Length 16mm, lot 9666776) being swapped with a single lot of 450.016 (4mm Cortex Standard Screw, length 16 mm, lot 9671879).
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 # 9666776 (catalog ID 450.136) and 9671879 (catalog ID 450.016)
- Product
- Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 30 units of Lot # 9666776 and 11 units of Lot # 9671879
- Distribution
- Worldwide Distribution - US Nationwide in the states of NC, CA, NY, TX, NJ, CO and the countries of: Ontario and Canada.
- Recall date
- April 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)