FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
- Recall number
- Z-1220-2017
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
- Status
- Terminated
- Initiated
- 2017-01-10
- Posted
- not on file
- Terminated
- 2018-03-26
- Reason
- The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
- 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
- 11
- Distribution
- Domestic: None VA/DOD: None Foreign: Japan
- Lot, serial or model codes
- 95-6104- Item No. 530430- Lot 1.5x4mm HT SD X-DR Screw
- 510(k) numbers
- ["K121589"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28