Z-0982-2015Class II

Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored...

Name: Z-0982-2015 Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored...
Creator: Biomet Spine, LLC
Published: 2013-08-22
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2013-08-22 / Terminated / root cause: design

FDA source

Biomet Spine, LLC began a recall of Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the... on 2013-08-22. FDA classified it as Class II and gives the reason as "The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly". 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-0982-2015
Classification: Class II
Status: Terminated
Initiated: 2013-08-22
Posted: 2015-01-15
Terminated: 2015-03-13
Recalling firm: Highridge Medical, LLC
Product: Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.
Root cause tag: design
FDA root cause: Component design/selection
Action: Distributors and Direct Sales Reps notified via letter to return product.
Quantity in commerce: 15
Distribution: Distributed in PR and the states of NY, AZ, TN, TX, and CA.
Product codes and lots: Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0982-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0982-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-15

Product code OVD

K123767Class IILanx Fusion System- SaLanx, Inc. / cleared 2013-03-18

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)