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.
FDA Recall Z-0833-2018 · Posted None
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Recalling FirmDePuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeHSD
Date Initiated2017-08-31
Date Terminated2020-03-12
Product Quantity23,053 units
Reason for Recall
The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationally
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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