Date Initiated by Firm | August 31, 2017 |
Create Date | March 01, 2018 |
Recall Status1 |
Terminated 3 on March 12, 2020 |
Recall Number | Z-0834-2018 |
Recall Event ID |
79115 |
510(K)Number | K120174 |
Product Classification |
Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
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Product | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only. |
Code Information |
5248487 5248488 5248489 5248490 5248491 5248497 5248498 5248499 5248500 5248501 5250420 5250421 5250422 5250423 5250424 5251136 5251137 5251138 5251139 5251140 5261339 5261340 5261341 5261342 5261343 5262077 5262078 5262079 5262080 5262081 5263090 5263091 5263203 5263204 5263205 5263206 5263798 5263799 5264519 5264520 5265494 5265495 5265496 5265497 5265498 5265499 5266088 5266089 5266090 5266592 5266593 5268090 5268091 5268092 5268093 5268474 5269235 5269741 5269742 5269743 5269744 5269745 5270942 5270943 5270944 5270945 5271415 5271416 5271417 5273260 5273261 5273262 5273263 5273264 5273265 5274694 5274695 5274696 5275978 5275979 5276798 5276799 5276800 5276801 5276802 5276803 5277832 5277833 5277834 5277835 5277836 5277843 5277844 5277845 5279892 5279893 5280180 5280181 5280182 5281491 5281492 5281493 5281494 5282646 5282647 5282648 5283244 5283245 5283246 5284416 5284417 5284418 5284419 5284420 5284421 5284422 5284991 5284992 5286447 5286448 5286449 5286684 5288257 5288258 5288259 5288478 5288479 5288480 5288481 5289306 5289307 5289308 5289309 5289311 5289599 5289600 5289601 5253183 5253184 5253185 5262086 5262087 5262088 5263207 5263208 5263800 5263801 5263802 5263803 5264934 5264935 5264936 5264937 5264938 5265500 5265501 5266594 5266595 5266596 5266597 5270354 5270355 5270356 5270946 5270947 5271418 5271419 5271420 5271421 5271422 5271423 5273266 5273267 5274697 5274698 5276804 5276805 5276806 5277846 5279354 5279355 5279356 5279894 5279895 5280183 5280184 5281495 5282649 5282650 5282651 5282652 5283247 5283248 5283249 5283250 5284423 5284424 5284425 5284426 5284993 5284994 5286685 5286686 5286687 5289312 5289313 5289314 5289315 5289607 5289608 5248482 5248483 5248484 5248485 5248486 5248492 5248493 5248494 5248495 5248496 5250425 5250426 5250427 5250428 5250429 5251141 5251142 5251143 5251144 5251145 5262082 5262083 5262084 5262085 5263209 5263210 5263211 5263212 5264521 5264939 5264940 5264941 5264942 5264943 5264944 5264945 5264946 5266598 5266599 5266600 5266601 5266602 5267247 5268475 5268476 5268477 5268478 5268479 5270357 5270358 5270359 5270948 5270949 5270950 5273268 5273269 5273270 5273271 5273272 5273273 5274699 5274700 5274701 5275980 5275981 5276807 5276808 5277837 5277838 5277839 5277847 5277848 5279357 5279358 5279359 5279360 5279361 5279362 5279363 5279364 5279365 5279366 5281496 5281497 5281498 5281499 5281500 5281501 5281502 5282653 5282654 5282655 5282656 5282657 5283251 5283252 5283253 5284427 5284428 5284429 5284995 5284996 5286450 5286451 5286452 5286453 5288260 5288261 5289316 5289317 5289318 5289319 5289320 5289614 5289615 5289616 5289618 5289619 5289620 5289621 5289622 5251938 5251939 5251940 5251941 5264014 5264044 5266091 5267248 5269071 5269072 5269073 5269074 5269075 5269076 5269077 5270360 5270361 5270362 5275982 5277840 5277841 5279891 5281503 5281504 5282527 5284412 5284413 5284414 5284415 5285764 5285765 5285766 5286454 5286455 5286456 5286688 5290272 5290273 5251942 5251943 5264015 5269078 5272192 5273274 5273275 5275983 5275984 5275985 5275986 5282658 5282659 5286457 5286458 5286459 5286460 5288482 5288483 5289321 5290274 5251944 5251945 5251946 5251947 5251948 5253698 5253699 5263912 5263913 5264947 5264948 5264949 5266092 5266093 5266603 5272193 5272194 5272195 5272196 5272197 5273276 5273277 5274702 5274703 5274704 5275987 5275988 5275989 5275990 5275991 5276809 5277842 5277849 5284430 5284431 5284997 5284998 5286461 5286462 5287323 5287324 5287325 5288262 5288484 5288783 5288784 5289322 5289323 5289324 5289625 |
Recalling Firm/ Manufacturer |
DePuy Orthopaedics, Inc. 700 Orthopaedic Dr Warsaw IN 46582-3994
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For Additional Information Contact | Complaints Team 574-371-7179 |
Manufacturer Reason for Recall | The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | On September 11, 2017 an URGENT MEDICAL DEVICE RECALL notice was issued to customers for specific lots of the DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants. The letter instructs customers to inspect inventory and to remove and return the affected lots to the recalling firm. Questions or concerns can be directed to Kim (Earle) Long, Senior Recall Coordinator, 574-371-4917. |
Quantity in Commerce | Quantities co-mingled under initial product |
Distribution | Nationally |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = KWS
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