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ATTUNE recallZ-0905-2015 · DePuy Orthopaedics, Inc. · initiated Nov 10, 2014

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.

FDA root cause category: Device Design

What the company is doing

DePuy Synthes sent an Urgent Information letter dated November 10, 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to complete the Hospital/User Facility Acknowledgement Car and return to their Deputy Orthopaedics Sales Consultant or fax to 574-371-4939. Customer swere also asked to retain a copy of the complete Acknnowlegement Card in their files along with the notice. Customers with questions were instructed to call 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT). For questions regarding this recall cal 574-371-4917.

Recall details

Recall number
Z-0905-2015
Status
Terminated
Initiated by the company
Nov 10, 2014
Posted by the FDA
Jan 5, 2015
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
4661
Product code
LXH
Distribution
Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).

Product description

Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).

Code information (models, lots, serial numbers)

CATALOG NO. : ATTUNE INTUITION Impactors  Femoral Impactor, (254401006)  Barcode GTIN Number:  Femoral Impactor, 10603295130222  ALL LOTS

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 70043).

Sources and updates

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