CrossCHECK Locking Screw in the following recall
CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF…
Why was CrossCHECK Locking Screw in the following recalled?
These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
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?
CrossCHECK Locking Screw with the following codes: REF CCP-L3008: Lot Number 35000; REF CCP-L3010: Lot Number 35000; REF CCP-L3012: Lot Number 35000-6, 35000; REF CCP-L3014: Lot Number 35000-8, 35000; REF CCP-L3016: Lot Number 35000; REF CCP-L3018: Lot Number 35000; REF CCP-L3020: Lot Number 35000; REF CCP-L3022: Lot Numbers: 35000-16-1, 35000; REF CCP-L3024: Lot Number 35000; REF CCP-L3026: Lot Number 35000; REF CCP-L3028: Lot Number 35000; REF CCP-L3030: Lot Number 35000; REF CCP-L3032: Lot Number 35000; REF CCP-L3034: Lot Number 35000; REF CCP-L3036: Lot Number 35000; REF CCP-L3038: Lot Number 35000; REF CCP-L3040: Lot Number 35000; REF CCP-L3508: Lot Number 35004; REF CCP-L3510: Lot Numbers: 35004-3, 35004; REF CCP-L3512: Lot Numbers: 35004-6, 35004; REF CCP-L3514: Lot Numbers: 35004-7, 35004; REF CCP-L3516: Lot Number 35004; REF CCP-L3518: Lot Numbers: 35004-12, 35004-12-1, 35004; REF CCP-L3520: Lot Numbers: 35004-13, 35004; REF CCP-L3522: Lot Numbers: 35004-16-1, 35004; REF CCP-L3524: Lot Numbers: 35004-18-1, 35004; REF CCP-L3526: Lot Number 35004; REF CCP-L3528: Lot Number 35004; REF CCP-L3530: Lot Number 35004; REF CCP-L3532: Lot Number 35004; REF CCP-L3534: Lot Number 35004; REF CCP-L3536: Lot Number 35004; REF CCP-L3538: Lot Number 35004; REF CCP-L3540: Lot Number 35004
- Product
- CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF…
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 107 units
- Distribution
- Nationwide Distribution
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)