—#152996

Product

1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K121589
Affected lot / code info: 95-6104- Item No. 530430- Lot 1.5x4mm HT SD X-DR Screw

Why it was recalled

The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Zimmer Biomet initiated a voluntary recall of 1.5mm System due to identification of non-conformance with off-centered slots and the no-go gage starting in the pilot hole. One distributor with affected product outside of Zimmer Biomet control was notified via email and asked to return the affected product. This communication was sent on via e-mail on January 10, 2017. All product has been returned.There were 89 units in Zimmer Biomet control at the time the removal was initiated, however all 100 are now in Zimmer Biomet control. Customer Service Zimmer Biomet, Inc. P.O. Box 708 Warsaw, IN 46581-0708 Phone: 800-348-2759

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Domestic: None VA/DOD: None Foreign: Japan

Timeline

Recall initiated: 2017-01-10
Terminated: 2018-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152996. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.