Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 51 of 125
Zimmer Biomet, Inc.
Class II Terminated
BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0298-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 3285509031...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0302-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0299-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0336-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 002348...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0313-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0327-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 47492800613 47492800702...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0312-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 ...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0323-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0310-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 47249318111 47249318113 47249318114 47249318209 472...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0337-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0328-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0332-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234801408 00234801410 ...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0315-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 00234700410 00234700412 002...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0307-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 0...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0305-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636 00151504836 00151505040 00151505240 00151505444 00151505644 00151505848 00151506048 00151506248 00151506...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0318-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0333-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 ...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0319-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414 47235700416 47235...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0309-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 ...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0329-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0326-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0303-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0306-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 0100551109 0100551110 0100551111 0100551112 010055111...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0320-2020 November 13, 2019 Warsaw, IN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Reason: There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac de...
Z-0239-2020 November 6, 2019 Mounds View, MN