Z-1220-2017Class II

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

Name: Z-1220-2017 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
Creator: Zimmer Biomet, Inc.
Published: 2017-01-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-01-10 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw on 2017-01-10. FDA classified it as Class II and gives the reason as "The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1220-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-10
Posted: 2017-02-16
Terminated: 2018-03-26
Recalling firm: Zimmer GmbH
Product: 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
Product code: HWC Screw, Fixation, Bone
Reason for recall: The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 11
Distribution: Domestic: None VA/DOD: None Foreign: Japan
Product codes and lots: 95-6104- Item No. 530430- Lot 1.5x4mm HT SD X-DR Screw

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1220-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1220-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-16

Product code HWC

K121589Class IIBiomet Microfixation Facial Plating SystemBiomet Microfixation / cleared 2012-09-21

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)