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VANGUARD 360 REVISION SYSTEM recallZ-0723-2021 · Biomet, Inc. · initiated Dec 1, 2020

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 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

Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

FDA root cause category: Process control

What the company is doing

.Zimmer Biomet issued Urgent Medical Device Recall letter issued on 12/1/20 to distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory will be notified via FedEx. Letter states reason for recall , health risk and action to take: Distributors esponsibilities include: locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 6. If you have further questions or concerns after reviewing this notice, please call 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-0723-2021
Status
Terminated
Initiated by the company
Dec 1, 2020
Recalling firm
Biomet, Inc.
Quantity
21 units
Product code
JWH
FDA submissions
K093293
Distribution
Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.

Product description

Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422

Code information (models, lots, serial numbers)

Lot Number: 098780  UDI Number: (01) 00880304482739 (17) 290501 (10) 098780

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

31 devices cleared under K093293 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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