Z-0708-2019Class II

Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120

Name: Z-0708-2019 Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120
Creator: Zimmer Biomet, Inc.
Published: 2018-11-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-11-20 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments... on 2018-11-20. FDA classified it as Class II and gives the reason as "One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0708-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-20
Posted: 2019-01-10
Terminated: 2020-04-14
Recalling firm: Zimmer GmbH
Product: Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone
Product code: LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Reason for recall: One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Zimmer Biomet issued Urgent Medical Device Recall letter on 11/20/18 advising of the problem, heath risk and action to be taken- Quarantine and return product. Complete Attachment 1 Certificate of Acknowledgement. Contact customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Quantity in commerce: 50 pieces
Distribution: Country of Japan
Product codes and lots: LOT 029980 UDI (01)00880304535589(17)280501(10)029980

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0708-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0708-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-16	2019-01-10
Z-0709-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-16	2019-01-10

Product code LXT

K112345Class IIDistal Volar Radius Plating SystemsMedos International SARL / cleared 2011-10-31

MDM coverage of this record lists here, newest first.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)