Skip to content
Recall Observatory FDA recall evidence

Device product

DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR

Z-1845-2021

May 07, 2021

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 87975
Status
Terminated
Classification
Class II
Quantity
50 units
Official record key
device-enforcement:Z-1845-2021

Official wording

Reason: Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.

Code information: Lot: D20111130 GTIN: 10603295033172

Distribution pattern: Domestic: CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI. Foreign: Bermuda

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.