Z-1069-2015Class II

Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device...

Name: Z-1069-2015 Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device...
Creator: Biomet Spine, LLC
Published: 2012-02-22
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2012-02-22 / Terminated / root cause: manufacturing process

FDA source

Biomet Spine, LLC began a recall of Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray... on 2012-02-22. FDA classified it as Class II and gives the reason as "Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature". 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-1069-2015
Classification: Class II
Status: Terminated
Initiated: 2012-02-22
Posted: 2015-02-09
Terminated: 2015-03-23
Recalling firm: Highridge Medical, LLC
Product: Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used with the Timberline Lateral System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Biomet initiated the recall on February 22, 2012, No letters were or will be sent to customers. 100% retrieval was achieved by working directly with the customers. For questions regarding this recall call 303-501-8548.
Quantity in commerce: 213
Distribution: Distributed to TX, IN, MO, and NY. No foreign/govt/military/VA.
Product codes and lots: Model #8734-2XXX, 8734-5XXX. Lot #L556219. Product Code: 8734-2060, CC Blade, 60mm 8734-2070, CC Blade, 70mm 8734-2080, CC Blade, 80mm 8734-2090, CC Blade, 90mm 8734-2100, CC Blade, 100mm 8734-2110, CC Blade, 110mm 8734-2120, CC Blade, 120mm 8734-2130, CC Blade, 130mm 8734-2140, CC Blade, 140mm 8734-2150, CC Blade, 150mm 8734-2160, CC Blade, 160mm 8734-2170, CC Blade, 170mm 8734-2180, CC Blade, 180mm 8734-5050, Posterior Blade, 50mm 8734-5060, Posterior Blade, 60mm 8734-5070, Posterior Blade, 70mm 8734-5080, Posterior Blade, 80mm 8734-5090, Posterior Blade, 90mm 8734-5100, Posterior Blade, 100mm 8734-5110, Posterior Blade, 110mm 8734-5120, Posterior Blade, 120mm 8734-5130, Posterior Blade, 130mm 8734-5140, Posterior Blade, 140mm 8734-5150, Posterior Blade, 150mm 8734-5160, Posterior Blade, 160mm 8734-5170, Posterior Blade, 170mm 8734-5180, Posterior Blade, 180mm

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1069-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1069-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-09

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)