Z-1691-2017Class II

Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM...

Name: Z-1691-2017 Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM...
Creator: Zimmer Biomet Spine, Inc
Published: 2017-03-16
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2017-03-16 / Terminated / root cause: design

FDA source

Zimmer Biomet Spine, Inc began a recall of Altius 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... on 2017-03-16. FDA classified it as Class II and gives the reason as "Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1691-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-16
Posted: 2017-03-28
Terminated: 2018-07-30
Recalling firm: Highridge Medical, LLC
Product: Altius 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 of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip.
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer Biomet sent an Urgent Medical Device Recall letter on March 20, 2017, to all affected consignees. The letter identified the product, the problem and the action to be taken by the consignee. Consignee's Responsibilities 1. Review this notification and ensure affected team members are aware of the contents. 2. Prior to sending Altius Kits to central processing, perform a functional check of the driver withall screws in the kit to ensure they mate. If the drivers do not mate, please return in accordance with Step 3b. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form Phase I. b. If the driver is unable to mate with the screws in the set, immediately sterilize and return the affected nonconforming product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form Phase I and Attachment 2 Certificate of Sterilization to Zimmer Biomet. i. For each return, send a copy of Attachment 1 to [email protected] ii. Include a hardcopy of Attachment 1 with your shipment for immediate processing. iii. Include a copy of Attachment 2 Certificate of Sterilization with returned instruments. iv. Mark the outside of the returns box(es) clearly with RECALL. 4. Distributors will notify their accounts to which the product was further distributed and to locate and return products from these accounts. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that have the affected product. If there are no additional users to notify, please confirm this by annotating and returning the form provided indicating that no additional users have been identified. 5. Retain a copy of your field action acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 6. If
Quantity in commerce: 141
Distribution: Worldwide Distribution - US (nationwide) and Internationally to the Netherlands
Product codes and lots: 505951,M16562R01,505951,510710,510981,514814,533566,536398,543663,546565,546566,549528,565465,565464,567525,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1691-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1691-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-28

Product code MAX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)