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 CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 x 20 mm, REF CCP-L3020; 3.0 x 22 mm, REF CCP-L3022; 3.0 x 24 mm, REF CCP-L3024; 3.0 x 26 mm, REF CCP-L3026; 3.0 x 28 mm, REF CCP-L3028; 3.0 x 30 mm, REF CCP-L3030; 3.0 x 32 mm, REF CCP-L3032; 3.0 x 34mm, REF CCP-L3034; 3.0 x 36 mm, REF CCP-L3036; 3.0 x 38 mm, REF CCP-L3038; 3.0 x 40 mm, REF CCP-L3040; 3.5 x 8 mm, REF CCP-L3508; 3.5 x 10 mm, REF CCP-L3510; 3.5 x 12 mm, REF CCP-L3512; 3.5 x 14mm, REF CCP-L3514; 3.5 x 16 mm, REF CCP-L3516; 3.5 x 18 mm, REF CCP-L3518; 3.5 x 20 mm, REF CCP-L3520; 3.5 x 22 mm, REF CCP-L3522; 3.5 x 24 mm, REF CCP-L3524; 3.5 x 26 mm, REF CCP-L3526; 3.5 x 28 mm, REF CCP-L3528; 3.5 x 30 mm, REF CCP-L3530; 3.5 x 35 mm, REF CCP-L3532; 3.5 x 34 mm, REF CCP-L3534; 3.5 x 36 mm, REF CCP-L3536; 3.5 x 38 mm, REF CCP-L3538; 3.5 x 40 mm, REF CCP-L3540 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.
- Company
- Wright Medical Technology, Inc.
- Recall Initiated
- July 21, 2015
- Posted
- September 1, 2015
- Terminated
- August 1, 2018
- Recall Number
- Z-2541-2015
- Quantity
- 107 units
- Firm Location
- Memphis, TN
Reason for Recall
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.
Distribution
Nationwide Distribution
Lot / Code Info
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
Root Cause
Employee error
Action Taken
Wright sent an Urgent Medical Device Recall letter dated July 20, 2015, to all affected customers. Customers were asked to complete the attached response form confirming receipt of the notice and the status of any products on hand, and return a copy to Wright by email (complaints@wmt.com or fax (901)867-7401. Also, if customers have any product in their inventory the product should be sent back to Arlington, TN (ALM). For questions regarding this recall call 901-290-5662.