Z-1735-2019Class II

Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to...

Name: Z-1735-2019 Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to...
Creator: Zimmer Biomet, Inc.
Published: 2018-11-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-11-14 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal... on 2018-11-14. FDA classified it as Class II and gives the reason as "Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1735-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-14
Posted: 2019-06-05
Terminated: 2020-05-12
Recalling firm: Zimmer GmbH
Product: Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 14, 2018, the firm sent an "Urgent Medical Device Recall" letters dated November 14, 2018, to its affected customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete the included Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-447-3625 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 64
Distribution: US Distribution to CA, NC, and NY; and International to Germany.
Product codes and lots: Lot M26888

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1735-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1735-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-05

Product code KWP

K151224Class IILineum OCT Spine SystemBiomet Spine / cleared 2015-06-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)