Device product
CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 18 mm, REF CCP-N3018; 3.0 x 20 mm, REF CCP-N3020; 3.0 x 22 mm, REF CCP-N3022; 3.0 x 24 mm, REF CCP-N3024; 3.0 x 26 mm, REF CCP-N3026; 3.0 x 28 mm, REF CCP-N3028; 3.0 x 30 mm, REF CCP-N3030; 3.0 x 32 mm, REF CCP-N3032; 3.0 x 34 mm, REF CCP-N3034; 3.0 x 36 mm, REF CCP-N3036; 3.0 x 38 mm, REF CCP-N3038; 3.0 x 40 mm, REF CCP-N3040; 3.5 x 8 mm, REF CCP-N3508; 3.5 x 10 mm, REF CCP-N3510; 3.5 x 12 mm, REF CCP-N3512; 3.5 14 mm, REF CCP-N3514; 3.5 x 16 mm, REF CCP-N3516; 3.5 x 18 mm, REF CCP-N3518; 3.5 x 20 mm, REF CCP-N3520; 3.5 x 22 mm, REF CCP-N3522; 3.5 x 24 mm, REF CCP-N3524; 3.5 x 26 mm, REF CCP-N3526; 3.5 x 28 mm, REF CCP-N3528; 3.5 x 30 mm, REF CCP-N3530; 3.5 x 32 mm, REF CCP-N3532; 3.5 x 34 mm, REF CCP-N3534; 3.5 x 36 mm, REF CCP-N3536; 3.5 x 38 mm, REF CCP-N3538; 3.5 x 40 mm, REF CCP-N3540. The CROSSCHECK Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet wrist and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.
Z-2542-2015
Product summary
- Event
- Event 71895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5687 units
- Official record key
device-enforcement:Z-2542-2015
Official wording
Reason: 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.
Code information: CrossCHECK Non-Locking Screw with the following codes: REF CCP-N3008: Lot Numbers: 34996-1, 34996-2, 34996-2-1, 34996; REF CCP-N3010: Lot Numbers: 34996-3, 34996-4, 34996-4-1, 34996; REF CCP-N3012: Lot Numbers: 34996-5, 34996-6, 34996-6-1, 34996; REF CCP-N3014: Lot Numbers: 10157-01, 34996-7, 34996-8, 34996-8-1, 34996; REF CCP-N3016: Lot Numbers: 34996-10, 34996-10-1, 34996-9, 34996; REF CCP-N3018: Lot Numbers: 34996-11, 34996-12, 34996-12-1, 34996; REF CCP-N3020: Lot Numbers: 34996-13, 34996-14, 34996-14-1, 34996; REF CCP-N3022: Lot Numbers: 34996-15, 34996-16, 34996-16-1, 34996; REF CCP-N3024: Lot Numbers: 34996-17, 34996-18, 34996-18-1, 34996; REF CCP-N3026: Lot Numbers: 34996-19, 34996-20, 34996-20-1, 34996; REF CCP-N3028: Lot Numbers: 34996-21, 34996-22, 34996-22-1, 34996; REF CCP-N3030: Lot Numbers: 34996-23, 34996-24, 34996-24-1, 34996; REF CCP-N3032: Lot Numbers: 34996-25, 34996-26, 34996-26-1, 34996; REF CCP-N3034: Lot Numbers: 34996-27, 34996-28, 34996-28-1, 34996; REF CCP-N3036: Lot Numbers: 34996-29, 34996-30, 34996-30-1, 34996; REF CCP-N3038: Lot Numbers: 34996-31, 34996-32, 34996-32-1, 34996; REF CCP-N3040: Lot Numbers: 34996-33, 34996-34, 34996; REF CCP-N3508: Lot Numbers: 1213, 34995-1, 34995-2, 34995; REF CCP-N3510: Lot Numbers: 0114, 34995-3, 34995-4, 34995; REF CCP-N3512: Lot Numbers: 0114, 34995-5, 34995-6, 34995; REF CCP-N3514: Lot Numbers: 0114, 34995-7, 34995-8, 34995; REF CCP-N3516: Lot Numbers: 0114, 34995-10, 34995-9, 34995; REF CCP-N3518: Lot Numbers: 0114, 34995-11, 34995-12, 34995; REF CCP-N3520: Lot Numbers: 0114, 34995-13, 34995-14, 34995; REF CCP-N3522: Lot Numbers: 0114, 34995-15, 34995-16, 34995; REF CCP-N3524: Lot Numbers: 0114, 34995-17, 34995-18, 34995; REF CCP-N3526: Lot Numbers: 0114, 34995-19, 34995-20, 34995; REF CCP-N3528: Lot Numbers: 34995-21, 34995-22, 34995-22-1, 34995; REF CCP-N3530: Lot Numbers: 34995-23, 34995-24, 34995-24-1, 34995; REF CCP-N3532: Lot Numbers: 34995-25, 34995-26, 34995-26-1, 34995; REF CCP-N3534: Lot Numbers: 34995-27, 34995-28, 34995-28-1, 34995; REF CCP-N3536: Lot Numbers: 34995-29, 34995-30, 34995-30-1, 34995; REF CCP-N3538: Lot Numbers: 34995-31, 34995-32, 34995-32-1, 34995; REF CCP-N3540: Lot Numbers: 34995-33, 34995-34, 34995-34-1, 34995
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.