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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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  Class 2 Device Recall Integra see related information
Date Initiated by Firm March 03, 2017
Create Date March 23, 2017
Recall Status1 Terminated 3 on May 21, 2018
Recall Number Z-1539-2017
Recall Event ID 76693
510(K)Number K091788  K050882  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Panta Nail, Rx only, Sterile,
Code Information Panta Nails -  Reference/Model #500050ND - Lot #'s: F33A, F33B, F3BN, F3Y5, F3Y6, F4S4, F56Y, F5LZ, F64W, F7C8, F7C9, F8SZ, F9PC, FCUG, FCUH, FEDW, FEVR, FGAX, FGLN and FHLP;  Reference/Model #500080ND - Lot #'s: F0F1, F64X, F81Y, F81Z, FEVS, FGLP and FGSK;  Reference/Model #500150ND - Lot #'s: F15L, F15L/1, F1ZQ, F27U, F27V, F3Y7, F5M0,F60W, F64Y, F64Z, F6L3, F7CA, F7CB, F7CC, F7CD, F821, F822, F8T1, F8T2, F9D6, F9D7, FEDX, FFB9, FG4T, FGSL and FHLR;  Reference/Model #500180ND - Lot #'s: F1ZS, F33C, F3M9, F4H4, F4ZZ, F68B, F823, F824, F8T3, FDEC, FEDY, FFBA and FFQL;  Reference/Model #500250ND - Lot #'s: EP14, F0WQ, F15M, F4H5, F500, F5M1, F650, F825, F826, F827, F828, F8T4, FGLQ and FGSM;  Reference/Model #500280ND - Lot #'s: F27T, F33D, F3BP, F3MA, F4H6, F5M2, F6L4, F829, F82A, F82B, F82C, F8T5 and FFBB;  Reference/Model #500350ND - Lot #'s: E2W1/1, F3BQ, F3MB, F3MD, F3Y8, F4H7, F5M3, F651, F6TT and FF3B;  Reference/Model #500380ND - Lot #'s: F3BR, F3MC, F4S5, F5M4, F60X, F652, F82D, F82E, F8T6 and FAF2  Panta XL Nails -  Reference/Model #510111ND - Lot #'s: F3H8, F4XA, F507, F5M5, F68C, F82F, F82G, F8T7, F9DC and F9DD;  Reference/Model #51014ND - Lot #'s: ELSS, EPFZ, F3H9, F82H, F82J, F8LG, FEVT and FFBC;  Reference/Model #510211ND - Lot #'s: F6JA, F82K, F82L, F8C8, F8T8, FFQN and FG4V;  Reference/Model #510241ND - Lot #'s: F5M6, F82M, F82N, F8C9 and F8T9;  Reference/Model #510311ND - Lot #'s: EPG0/1, EPG0/2, EPG0/3, EPG0/4, EPG0/5, F82P, F82Q and F8TA;  Reference/Model #510341ND - Lot #'s: F4H8, F508, F657 and F8TB
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Dr. Patricia Kihn
717-309-3966
Manufacturer 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.
FDA Determined
Cause 2		 Packaging change control
Action Integra sent "Urgent Medical Device Recall Letters and Return Response Forms" dated March 3, 2017 to their distributors and customers. All customers were asked to examine their inventory to determine if they had the recalled lots and if they did they are instructed to stop using them immediately. Distributors are asked if the recalled product was further distributed, those customers should be notified and instructed to follow the recalling procedures. The return response form should be completed, even if they do not have any recalled lots, annotating the amount of product and list a record of the lot numbers. The return response form should be sent back to Integra via email to: FCA2@integralife.com or via fax to: 1-609-750-4220. Upon receipt by Integra, if your company has identified recalled lots, Customer Service will contact the customer and provide an RMA number and directions to return the product, as well as input an order to replace the quantity indicated on the return response form. Should any customer have any questions regarding the recall instructions, they can contact Customer Service at 1-800-654-2873. To return units under field inventory, customer can contact 1-888-601-0203, option 2. For further questions, please call (717) 309-3966.
Quantity in Commerce 4,449 units
Distribution US Nationwide and Internationally
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = NEWDEAL S.A.
510(K)s with Product Code = HSB and Original Applicant = NEWDEAL SAS
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