FDAFDA · Food and drugs·Recall number Z-1539-2017
Panta Nail, Rx only, Sterile,
Published March 29, 2017 · Recall initiated: March 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- US Nationwide and Internationally
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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