Recall Z-2541-2015 ยท HRS Plate, Fixation, Bone
Wright Medical Technology, Inc.
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, RE
| Date | Sep 1, 2015 (initiated Jul 21, 2015) |
| Status | Terminated |
| 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. |
| Root 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 | 107 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132594 | CROSSCHECK PLATING SYSTEM Solana Surgical, LLC, Dec 13, 2013 |