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,
FDA device recall Z-2542-2015 · posted 2015-09-01 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology, Inc.
- 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.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 5687 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-07-21
- Date posted
- 2015-09-01
- Date terminated
- 2018-08-01
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CROSSCHECK PLATING SYSTEM (K132594) | Solana Surgical, LLC | 2013-12-13 |