Device recall: Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided…

Class II FDA enforcement event 70381. Recall start date: 22 Feb 2012. Status in the FDA record: Terminated. Termination date: 23 Mar 2015.

Reason for recall, in the words of FDA

Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.

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 22 Feb 2012. The firm address in the FDA record is in Broomfield, CO. FDA put the recall in Class II. FDA event 70381 has 1 product record. The first FDA enforcement report date is 18 Feb 2015. The record gives the status Terminated, with the termination date 23 Mar 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.

Distributed to TX, IN, MO, and NY. No foreign/govt/military/VA.

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 70381: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1069-2015	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…	213	Class II	Terminated	18 Feb 2015

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 2012: 823
Share of these events in Class II: 88%
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-1069-2015The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 70381. https://recallregister.com/fda/ii/70381/. 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: Distributed to TX, IN, MO, and NY. No foreign/govt/military/VA.
What quantity of product is in FDA event 70381?: The FDA record gives this quantity: 213
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 88% of the 823 device events that started in 2012 are in Class II.