Recall Z-1539-2017— Integra LifeSciences Corp.

Name: FDA recall Z-1539-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-03

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2017-03-03, terminated 2018-05-21. It names 2 FDA 510(k) clearances: K091788, K050882. Product: Panta Nail, Rx only, Sterile,. Reason: Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2017-03-03
Terminated: 2018-05-21
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K091788 — PANTA NAIL (DIA. 10MM), PANTA NAIL XLNewdeal Sas·cleared 2009-07-29
K050882 — NEWDEAL ANKLE NAILNew Deal, S.A.·cleared 2005-05-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Panta Nail, Rx only, Sterile,

Reason for recall

Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.

Data sourced from openFDA. This site is unofficial and independent of the FDA.