FDAClass IISeptember 21, 2016

Integra Meshed Dermal Regeneration Template 5 cmx 5 cm recall

Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a…

Why was Integra Meshed Dermal Regeneration Template 5 cmx 5 cm recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalogue No. MIDRT 8101 Lot No. 105A00324750

Product
Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a…
Recalling firm
Integra LifeSciences Corporation
Quantity
14 packages
Distribution
Nationwide Distribution to PA
Recall date
September 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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