FDA Device recall Z-2542-2015
CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008 by Wright Medical Technology, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2542-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-21 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Wright Medical Technology |
| Distribution | US |
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.
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.
Identifiers
| code_info | CrossCHECK Non-Locking Screw with the following codes: REF CCP-N3008: Lot Numbers: 34996-1, 34996-2, 34996-2-1, 3499…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2542-2015%22
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