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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

NewDeal SA: Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

Agency Publication Date: July 16, 2018
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Affected Products

Product: UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S

330021S - Lot # F8ML, FEDJ & FF38 330023S - Lot # EF05/G, EGNK/G, F8MM, F9J2, FAPZ, FBE8, FBPB, FCFQ, FCJP, FEDK, FF39 & FFH7 330025S - Lot # FAE6, FBPC, FCFR, FCJQ, FEDL & FFH8 330030S - Lot # EMGF/1, ENHN, EPQM-FBE5, FBPD, FBPE, FBPF, FEDM, FEXQ, FEXR, FFH9 & FGHY 330217S - Lot # F7BY, F7BZ, F7C0-F7C1, F7MV, F98K, F9K7, FAFY, FAQ0, FC2Y, FCJR, FEDN, FEDP, FFHA, FFHB 330220S - Lot # F7C2, F7C3, F7C3/1, F7MW, F8KW, F8WR, F9J1, FAQ1, FBP3, FC2Z, FD69, FEDQ, FEDR, FGNC & FHLM 330225S - Lot # F7N0, F8P5, F8WS-, FAQ2, FBP4, FEDS & FHLN 330230S - Lot # F7MX, F8WT, F9SZ, FAFZ, FBE6, FEDT, FEDT/1 & FEDT/Q 330420S - Lot # F7C4, F7MY, F8WU, F942, F9CK, FA80, FB9L, FBPG, FEDU & FGJD 330425S - Lot # F7MZ, F8P6, F8XQ, F9K8, FB4X, FBPH, FBPJ, FF3A & FFHD 330430S - Lot # F7C5, F9EU, F9SY, FA81, FB9M, FBE7, FBPK, FEDV & FFHE

Lot Numbers:
F8ML
EF05
FAE6
EMGF
F7BY
F7C2
F7N0
F7MX
F7C4
F7MZ
F7C5
Product: ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S

181011S - Lot # E8PF/G, F5CE 181012S - Lot # E8MB/G, E8MV/G & E8PG/G1 181013S - Lot # E8MC/G, E8MW/G, E8NF/G, E8NF/G1, E8NZ/G, E8PH/G, F538, F5CG & F7G7 181014S - Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1 181001S - Lot # E8PB/G & F5CA 181002S - Lot # E8M7/G, E8MR/G & E8PC/G 181003S - Lot # E8MS/G, E8NB/G, E8NV/G, F537 & F5CC 181004S - Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1

Lot Numbers:
E8PF
E8MB
E8MC
E8MD
E8PB
E8M7
E8MS
E8MD
Product: ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S

181051S - Lot # FCK9, FG3H & FG3J 181052S - Lot # E8PA/G & EB1H/G 181041S - Lot # F0AS, F0AT & F0AU 181042S - Lot # E8P8/G & EB1F/G 181031S - Lot # E8N2/G, E8NL/G, E8P4/G, E8PS/G, EBKW/G, EBKW/G1 & F8EH 181032S - Lot # E8P5/G, E8P5/G1, E8PT/G, EB1C/G, EBKX/G & F8EJ 181033S - Lot # E8PU/G 181021S - Lot # E8NH/G & E8P1/G-EB18/G 181022S - Lot # E8MF/G, E8MF/G/Q, E8PQ/G & EBKU/G 181023S - Lot # E8MG/G, E8P3/G, E8PR/G & F8EG

Lot Numbers:
FCK9
E8PA
F0AS
E8P8
E8N2
E8P5
E8PU
E8NH
E8MF
E8MG
Product: Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S & 121820S

111740S - Lot # F6H4, F70W, F9B8, F9MY, FAJ6, FATG, FBHN, FC9D, FD33, FD34, FD35, FDQR, FDQS, FELG, FEW0, FF8X, FGA8, FGCS, FH80 111745S - Lot # F6H5, F8S3, F9R8, FA4X, FAJ7, FB30, FBHP, FBRR, FBWE, FC0A, FE0C, FELH, FELJ, FEW1, FGCT & FHKY 111750S - Lot # F70X, F7VP, F7VQ, F7VR, F9Z0, FA4Y, FAP1, FB38, FBHQ, FC0B, FD36, FD37, FD38, FE0D, FE0E, F7VR, F9Z0, FA4Y, FAP1, FB38, FBHQ, FC0B, FD36, FD37, FD38, FE0D, FE0E, FE0F, FELK, FEW2, FF16, FF4V, FF8Y, FF8Z, FFVR, FG3M, FG3N, FH82 & FHCM 111755S - Lot # F5Q7, F6H6, F7VS, F7VT, F7VU, FAJ8, FATF, FBHR, FBRS, FCAL, FE0G, FE0H, FE0J, FELL, FELM, FF4W, FF90, FFVS, FFVT, FGCU, FH83 & FHCP 111760S - Lot # F5Q8, F6H7, F6H8, F7VV, F7VW, F9Z1, FA4Z, FAP2, FB31, FB3C, FBHS, FBWP, FD39, FD3A, FD3B, FD3C, FE0K, FE0L, FE0M, FE0N, FE0P, FEW3, FF4X, FF91-FF92, FFVU, FFVV, FFVW, FGCV & FHCR 111765S - Lot # F5Q9, F6H9, F7VX, F7VY, F7VZ, F9Z2, FA50, FAP3, FB29, FBHT, FBWF, FD3D, FD3E, FD3F, FE0Q, FE0R, FE0S, FE0T, FE0U, FF4Y, FFVX, FFVY, FHCU & FHCV 111770S - Lot # F5QA, F6QQ, F70Y, F9E9, FA51, FA5L, FB32, FB3D, FBWQ, FE0V, FE0W, FE0X, FELN, FEW4, FF4Z & FFVZ 111775S - Lot # F6HA, F70Z, F9B9, F9Z3, FA53, FB39, FBWG & FF50 111780S - Lot # F61H, F710, F8S4-F9RQ, F9Z4, FA54, FB2A, FB33 & FBWH 111785S - Lot # F61J, F6HB, F711, F8S5, F9N1, F9RR, F9Z5, FA55, FB2B, FBWJ, FBWJ/1 & FHCW 111790S - Lot # F5QB, F712, F7W0, F7W1, F7W2, F9RS, F9Z6, FA56, FB2C, FB3A & FBWK 111795S - Lot # F6HC, F7W3, F7W4, F9EA, F9RT, F9Z7, FA57, FBWL, FE0Y-FE0Z, FELP, FEW5 & FF52 111800S - Lot # F5LE, F61K, F7W5, F7W6, F9R9, F9RA, F9Z8, FA58, FAP4, FB2D, FB3B, FBWM, FDQT, FDQU, FELQ, FELR, FEW6 & FGCW 111805S - Lot # F5QC, F6HD, F8S6, F9PV, F9Z9, FA59, FAP5, FBWN, FD3G, FE10, FELS, FELT, FF55, FF93, FFW4, FH4V, FHL0 & FH4U 111810S - Lot # E62H/G, F5LF, F7W7, F9PW, FATE, FBHU, FC0C, FD3H, FD3J, FE11, FELU, FELV, FF56, FFW5, FGA9 & FGCX 111815S - Lot # F7RW, F7W8, F9EB, FAJ9, FBEA, FBRT, FD3K, FD3L, FE12, FELW, FEW7, FF57, FFW6 & FGCY 111820S - Lot # E62K/G, F5LG, F7W9, F9EC, F9RB, FBHV, FC9E, FD3M, FD3N, FDQV, FELX, FELY, FELZ & FGAA 121740S - Lot # F7WH, FAJD, FB2R, FBJ5, FD83, FE1F, FE1G, FEX3, FF9G & FGD4 121745S - Lot # F6BV, F7WJ, F9BC, FAJE, FB2S, FBJ6, FC2J, FD84, FE1H, FE1J & FFX8 121750S - Lot # F6HN, F7WK, F8YB, F9U8, FA4M, FAP7, FB2H, FBJ7, FC2K, FD85, FD86, FE1K, FE1L, FFX9, FFXA & FGD5 121755S - Lot # F6HP, F7WL, FAJF, FB2J, FBJ8, FBRV, FC2L, FD87, FE1M, FE1N, FF9H, FFXB & FHL1 121760S - Lot # F6HQ, F7WM, FAH2, FB2V, FB88, FBJ9, FD89, FE1P, FE1Q, FEX4, FHDB & FHDB/1 121765S - Lot # F6HR, F8BW, F9U9, FB2T, FBJA, FD8A, FD8B, FE1R, FE1S, FFXC & FH84 121770S - Lot # F64T, F6HS, F7WW, F9RD, FA4N, FB2W, FBWT, FE1T, FFXD, FH85 & FH85/1 121775S - Lot # F6HT, F8YC, F9PX, F9UA, F9ZD, FA4P, FBWU, FDQW, FDQX, FDQY, FDQZ, FE1U & FFXF 121780S - Lot # F6HU, F7JQ, F9UB, FA4Q, FAP8, FBJB, FBWV, FC2M, FDR0, FDR1, FDR2 & FDR2/1 121785S - Lot # F60U, F6HV, F7WN, FAJG, FBJC, FD8C, FD8D, FD8E, FE1V, FEX5, FH54 & FH54/1 121790S - Lot # F8YD, FB2X, FCAJ, FE1W, FEX6, FFXG & FH86 121795S - Lot # F6HW, F7BH, FBRW, FCCC, FE1X, FE1Y, FF9K, FGAC & FHDE 121800S - Lot # F6AR, FCAM, FD8F, FE1Z, FF9L, FF9M, FH55, FH87 & FH87/1 121805S - Lot # F6HX, F9FN, FCAK, FE20, FF9N & FGD6 121810S - Lot # F5LK, F7WP, F9RE, FD8G, FE21, FEX7, FF9P & FFXH 121815S - Lot # F7WQ, FBJD, FCCD, FD8H, FE22, FF9Q, FF9R & FGAD 121820S - Lot # F9BD, FBJE, FD8J, FD8K, FE23, FF9S & FG3P

Lot Numbers:
F6H4
F6H5
F70X
F5Q7
F5Q8
F5Q9
F5QA
F6HA
F61H
F61J
F5QB
F6HC
F5LE
F5QC
E62H
F7RW
E62K
F7WH
F6BV
F6HN
F6HP
F6HQ
F6HR
F64T
F6HT
F6HU
F60U
F8YD
F6HW
F6AR
F6HX
F5LK
F7WQ
F9BD
Product: TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S

150010S - Lot # F8X6 - F9K6 - F9YE-F9YH - FAC1 - FAFD-FBTV - FC90 - FC93-FD10 - FGL3 - FGL3/1- 150020S - Lot # F6R7 - F6R8 - F6R9-F8X7 - F8X8 - F9MH -FAA6 - FAU7 - FAU8-FAZW FAZX - FAZY-FD11 - FD12 - FFGP-F8X7 - F8X8 - F9MH -FAA6 - FAU7 - FAU8-FAZW FAZX - FAZY-FD11 - FD12 - FFGP-FGL1 - FGL2 - FH73-FH7S - FH7T & FJ4J 150030S - Lot # FGM5 FHRR 150040S - Lot # F6RA - F6RB - F7PB-F9KG FAFE - FBTT-FC91 - FGL0 - FH7U 150120S - Lot # F77H - F77J - F77K-F9MJ - F9YF - F9YG-FAA7 FAZZ - FBTU-FC92 - FCV9 - FFGR-FGGY FGGZ - FGM8-FGM9 - FH7W - FHK2 150110S - Lot # F97D - F9KH - FAU9-FCN0 FGGW - FGM7-FH7V & FJ4G 150130S - Lot # EB5W/G - EDJX/G FAUA - FG0J & FJ4J 150200S - Lot # F6RR - F7X0 - F98B-FAWZ - FD8L - FD8M-FE2T - FEX8 150240S - Lot # F6RS - F88U - F9F1-FBBS - FD8N - FD8P-FE2U - FE2V - FE2W-FEX9 - FF1M - FFPT-FGNW - FGNX & FGNY 150242S - Lot # F6RU - F88V - F98F-FAX0 - FCB9 - FE2X-FE2Y - FE2Z - FF1N-FFPU FFPV - FGNZ-FGX2 & FG7K 150246S - Lot # F6RV - F88W - F9F2-FBBT FCBA - FD8Q-FE30 - FE31 - FE32-FE33 FEXA - FF1P-FFPW - FG7L - FGP0-FGX3 150250S - Lot # F6RW - F88X - F9F3-FBBU FCPQ - FDSB-FDSC - FE34 - FE35-FEXB - FF1Q - FFPX -FG7M - FG7N - FGX4 & FHGG 150255S - Lot # F6YN - F6YN/1 - F6YN/2-F6YN/3 - F6YN/4 - F6YN/5 - F6YN/A--- 150260S - Lot # F6RX - F7X1 - F8XU-F9F5 - FAX1 - FBBV-FCPR - FD8R - FE36-FE37 - FF1R - FFPY-FG7P 150265S - Lot # F6RY - F88Y - F989-F9F6 - F9VA - FCBB-FDSD - FE38 - FFPZ-FG7Q - FH2T- 150270S - Lot # F6RZ - F8LD - F9BX-F9VB FBBW - FD8S-FE39 - FF1S - FG7R & FHGJ 150275S - Lot # F6S0 - F88Z - F98A-F9BW FBBX - FCPS-FE3A FEXC 150280S - Lot # F6S1 - F7X2 - F98D-FAPQ FBBY - FCPT-FE3B - FF1T - FG7S-- 150285S - Lot # F6S2 - F7X3 - F9F7-FBBZ - FD8T - FE3C-FF1U - FG7T 150290S - Lot # EB7X/G - F6S3 - F890-F98G - FBC0 - FCPU-FDSE - FE3D - FF1V & FH2U 150514S - Lot # EA0T/G - F6W9 - F7Z1-F8EB FAXQ - FCGX-FEHH FEXD - FG1C 150516S - Lot # F6WA - F7Z2 - F8EC-FAY4 FCGY - FEHJ-FEXE - FG1D

Lot Numbers:
F8X6
F6R7
FGM5
F6RA
F77H
F97D
EB5W
F6RR
F6RS
F6RU
F6RV
F6RW
F6YN
F6RX
F6RY
F6RZ
F6S0
F6S1
F6S2
EB7X
EA0T
F6WA

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80312
Status: Resolved
Manufacturer: NewDeal SA
Manufactured In: France
Agency Last Updated: December 18, 2018

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.