Food, drugs, devices › Biomet Spine, LLC

Device recall: 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOL

FDA enforcement event 73402 · Class II · initiated 12 Feb 2016 · status Terminated · terminated 10 May 2016

DeviceVoluntary: Firm initiated1 product recordBroomfield, CO

FDA enforcement event 73402 is a device recall by Biomet Spine, LLC of Broomfield, CO, initiated 12 Feb 2016 and classified Class II, with 1 product record.

FDA defines Class II as 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 10 May 2016. Initiation: voluntary: firm initiated. Biomet Spine, LLC has 13 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Biomet Spine, LLC, Broomfield, CO.

Reason for recall

"Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees."

Distribution

"Worldwide Distribution - US Nationwide - one foreign consignee (not Canada)."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1253-2016	10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in…	10	Class II	Terminated	6 Apr 2016

Context

91%of 2016 device events are Class II1,232 events that year

1product record in this eventfirm median: 1

13events on this register for the firm

Other enforcement events for Biomet Spine, LLC

Initiated	Product (first record)	Type	Class	Records
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. 86300204 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
22 Feb 2012	Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided wi	Device	Class II	1

All 13 events for Biomet Spine, LLC

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide - one foreign consignee (not Canada)."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 10 May 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.