Z-0978-2015Class II

Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline...

Name: Z-0978-2015 Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline...
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 Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the... on 2013-08-22. FDA classified it as Class II and gives the reason as "The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft". 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-0978-2015
Classification: Class II
Status: Terminated
Initiated: 2013-08-22
Posted: 2015-01-14
Terminated: 2015-03-13
Recalling firm: Highridge Medical, LLC
Product: Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help 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 inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, Lanx, sent their Consignees/customers a letter dated October 15, 2013. The letter described the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with the conforming product. Please contact the Chief Compliance Officer at 303-501-8534 or by email: [email protected].
Quantity in commerce: 12 units
Distribution: US Distribution to states of: AZ, CA, NY, TN, and TX including PR.
Product codes and lots: Model 8630-0204 Lots TU00052, TU00052A, and TU00117

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0978-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0978-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14

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)