Class 2 Device Recall CrossCHECK Locking Screw

• Date Initiated by Firm: July 21, 2015
• Date Posted: September 01, 2015
• Recall Status: Terminated on August 01, 2018
• Recall Number: Z-2542-2015
• Recall Event ID: 71895
• 510(K)Number: K132594
• Product Classification: Plate, fixation, bone - Product Code HRS
• 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.
• 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
• Recalling Firm/ Manufacturer: Wright Medical Technology, Inc.; 1023 Cherry Rd; Memphis TN 38117-5423
• For Additional Information Contact: Amanda Clark, PhD; 901-290-5662
• Manufacturer 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.
• FDA Determined Cause: Employee error
• Action: 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.
• Quantity in Commerce: 5687 units
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HRS