—#135254

Product

CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K132594
Affected lot / code info: Lot Numbers: 3504927, 35049-27A, 35049-27A-1, 35049-28, 362801, 36280-1-1, 8752-010381

Why it was recalled

The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Firm has initiated the recall on 03/06/2015 through written communication via Fed Ex P1 delivery to all Wright Medical Technologies distributors (hubs). Follow-up to non-responding consignees will commence 30 days after initiation. Effectiveness checks will be performed through the confirmation of returned product via a validated ERP system, a returned/signed verification form, and in the case of non-responders, a phone call, e-mail or follow up letter, depending on the region and availability of consignee.

Recalling firm

Firm: Wright Medical Technology, Inc.
Address: 1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2015-03-06
Posted by FDA: 2015-04-22
Terminated: 2018-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135254. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.