Integra LifeSciences Corporation

FDA recalling firm · 7 enforcement events · 29 product records · 2012–2016 · NJ, OH

Integra LifeSciences Corporation has 7 FDA enforcement events on this register (29 product records) between 2012 and 2016: 7 device; the busiest year was 2012 with 2.

0% of its events are Class I; the most common class is Class II (7). 0 events are listed as ongoing; the recalling firm's address is in NJ and OH.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
11 Mar 2016	Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan…	Device	Class II	1	Terminated
19 Dec 2014	The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical…	Device	Class II	1	Terminated
28 Mar 2014	Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle,…	Device	Class II	1	Terminated
9 May 2013	Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.	Device	Class II	1	Terminated
28 Mar 2013	Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..	Device	Class II	21	Terminated
5 Nov 2012	MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support…	Device	Class II	2	Terminated
9 Aug 2012	Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a…	Device	Class II	2	Terminated

By type and class

Device7

Class II7

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Integra LifeSciences Corporation by year initiated.

Questions and answers

How many FDA recalls has Integra LifeSciences Corporation had?

7 enforcement events (29 product records) on this register, 2012–2016: 7 device.

Are any Integra LifeSciences Corporation recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Integra LifeSciences Corporation recalls?

7 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.