Device recall: LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant…

Class II FDA enforcement event 69615. Recall start date: 9 Mar 2011. Status in the FDA record: Terminated. Termination date: 7 Jan 2015.

Reason for recall, in the words of FDA

Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Biomet Spine LLC. started this device recall on 9 Mar 2011. The firm address in the FDA record is in Broomfield, CO. FDA put the recall in Class II. FDA event 69615 has 1 product record. The first FDA enforcement report date is 26 Nov 2014. The record gives the status Terminated, with the termination date 7 Jan 2015.

FDA enforcement report The 1 product record

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 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,

Recalling firm

Biomet Spine LLC., Broomfield, CO.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 69615: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0220-2015	LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.	120	Class II	Terminated	26 Nov 2014

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2011: 114
Share of these events in Class II: 89%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 13

Other events of the firm

Other FDA enforcement events of Biomet Spine LLC.
Initiated	Product (first record)	Type	Class	Records
12 Feb 2016	10mm X 12o Solitaire Ti Medium Spacer – Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOL	Device	Class II	1
29 Sep 2015	MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate	Device	Class II	1
5 Aug 2015	Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.	Device	Class II	1
22 Jul 2015	Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusabl	Device	Class II	1
12 Mar 2015	Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-58302	Device	Class II	1
12 Mar 2015	Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of t	Device	Class II	2
22 Aug 2013	Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable	Device	Class II	1
22 Aug 2013	Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 8630‐0204 Timberline Anchored Late	Device	Class II	1
22 Aug 2013	Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retrac	Device	Class II	1
30 Nov 2012	Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium a	Device	Class II	1

Biomet Spine LLC.: all 13 events

Official channels

FDA enforcement report Z-0220-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 69615. https://recallregister.com/fda/ii/69615/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
What quantity of product is in FDA event 69615?: The FDA record gives this quantity: 120
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2011 have the same class?: 89% of the 114 device events that started in 2011 are in Class II.