Recall Register

Zimmer Biomet Spine Inc.: FDA recalls

FDA enforcement reports name Zimmer Biomet Spine Inc. as the recalling firm in 5 events. The events have 8 product records. The recalls started from 2016 to 2023. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

5 events, newest first.

FDA enforcement events of Zimmer Biomet Spine Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
16 Oct 2023Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation SystemDeviceClass II1Ongoing
30 Jul 2018Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the…DeviceClass II3Terminated
10 May 2017Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle – 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017DeviceClass II1Terminated
16 Mar 2017Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration…DeviceClass II1Terminated
30 Jun 2016Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.DeviceClass II2Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Zimmer Biomet Spine Inc.: events for each product type
TypeEvents
Device5
Zimmer Biomet Spine Inc.: events in each class
ClassEvents
Class II5
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Zimmer Biomet Spine Inc., by the year that the recall started. The largest year is 2017, with 2 events.

Official channels

Cite this page

Recall Register. Zimmer Biomet Spine Inc.: FDA recalls. https://recallregister.com/firm/zimmer-biomet-spine-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
CO

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Zimmer Biomet Spine Inc. have?
Class II: 5 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Zimmer Biomet Spine Inc.?
FDA event 93650, which the firm started on 16 Oct 2023. The first product in the record is: Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
How many FDA recalls of Zimmer Biomet Spine Inc. have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.