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Arcos Modular Revision Hip System recallZ-2820-2018 · Zimmer Biomet, Inc. · initiated Jun 8, 2018

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 Zimmer Biomet, 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

Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

FDA root cause category: Process control

What the company is doing

The firm sent an initial email on June 6, 2018, to US distributors that received affected product. Distributors were asked to quarantine any affected product on hand. The formal recall notice was then prepared and emailed to distributors on June 8, 2018. On the same day, hospital risk managers and distributors received notification via courier. " The distributors notice identified the issue and their responsibilities. These responsibilities included locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. " Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. " The hospital risk manager notice identified the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product - Returning Certificate of Acknowledgement to Zimmer Biomet. If you have further questions or concerns after reviewing this information, please call Zimmer Biomet customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].

Recall details

Recall number
Z-2820-2018
Status
Terminated
Initiated by the company
Jun 8, 2018
Recalling firm
Zimmer Biomet, Inc.
Quantity
12
Product code
JDI
FDA submissions
K090757
Distribution
US distribution to CA, GA, IL, MO, NY, and VA.

Product description

ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.

Code information (models, lots, serial numbers)

lot 621550 UDI (01)00880304474154(17)280206(10)621550

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

2 devices cleared under K090757 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 80534).

Sources and updates

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