FDAClass IIJune 16, 2021

DePuy Synthes Articul/eze Femoral Head: Hip joint recall

DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description…

Why was DePuy Synthes Articul/eze Femoral Head: Hip joint recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: D20111130 GTIN: 10603295033172

Product
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description…
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
50 units
Distribution
Domestic: CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI. Foreign: Bermuda
Recall date
June 16, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls