Recall Z-3334-2026 ยท HRS Plate, Fixation, Bone
Wright Medical Technology, Inc.
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
| Date | Oct 1, 2026 (initiated Aug 18, 2026) |
| Status | Open, Classified |
| Reason | Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement device is readily available. |
| Root cause | Process control |
| Action | On 8/13/2026, recall notices were mailed and emailed to customers who were asked to do the following: 1) Review the product issue and risks as communicated in this Recall Notice and communicate the issue as appropriate in your organization. 2) Sign and return the enclosed business reply form by email to memphis.fieldaction@stryker.com 3) Upon receipt of the completed business reply form, firm will arrange for product return. 4) If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification l |
| Quantity | 34 |
| Distribution | US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133715 | CHARLOTTE CLAW PLATE SYSTEM Wrightmedicaltechnologyinc, Feb 28, 2014 |