Food, drugs, devices › Integra LifeSciences Corporation
Device recall: Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template
Integra LifeSciences Corporation (Plainsboro, NJ) initiated this device recall on 11 Mar 2016; FDA lists 1 product record under event 73689, classified Class II.
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 13 Sep 2016. Initiation: voluntary: firm initiated. Integra LifeSciences Corporation has 7 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
Integra LifeSciences Corporation, Plainsboro, NJ.
Reason for recall
"Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was incorrectly calculated for a single Lot (Lot 105A00324750)."
Distribution
"Nationwide Distribution to PA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2777-2016 | 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… | 14 packages | Class II | Terminated | 21 Sep 2016 |
Context
Other enforcement events for Integra LifeSciences Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Dec 2014 | The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ab | Device | Class II | 1 |
| 28 Mar 2014 | Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number | Device | Class II | 1 |
| 9 May 2013 | Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the | Device | Class II | 1 |
| 28 Mar 2013 | Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is a | Device | Class II | 21 |
| 5 Nov 2012 | MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Mo | Device | Class II | 2 |
| 9 Aug 2012 | Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW | Device | Class II | 2 |
All 7 events for Integra LifeSciences Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was incorrectly calculated for a single Lot (Lot 105A00324750)."
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: "Nationwide Distribution to PA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Sep 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.