FDA Device recall Z-0833-2018

DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoul…

FDA Device
Class II
terminated
Published 2018-03-07

On 2018-03-07 the FDA classified a Class II recall of DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoul… by Depuy Orthopaedics, citing the affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0833-2018
Classification	Class II
Status	terminated
Initiated	2017-08-31
Published	2018-03-07
Last updated	2026-09-13 11:54 UTC
Company	Depuy Orthopaedics
Distribution	n/a

Product

DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are 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.

Reason

The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.

Identifiers

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code_info

5248487 5248488 5248489 5248490 5248491 5248497 5248498 5248499 5248500 5248501 5250420 5250421 5250422 52…

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 5

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0833-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.