—#153928

Product

Panta Nail, Rx only, Sterile,

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K050882, K091788
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: US Nationwide and Internationally

Timeline

Recall initiated: 2017-03-03
Terminated: 2018-05-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153928. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.