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Compress Device recallZ-0376-2024 · Biomet, Inc. · initiated Oct 9, 2023

Open, Classified

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

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

FDA root cause category: Device Design

What the company is doing

Zimmer Biomet issued Urgent Medical Device Recall letter on 10/09/23 to Distributors and Risk Managers via email/courier . Letter states reason for recall, health risk and action to take: 1. 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 facility s 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-0376-2024
Status
Open, Classified
Initiated by the company
Oct 9, 2023
Posted by the FDA
Nov 21, 2023
Recalling firm
Biomet, Inc.
Product code
KWA
FDA submissions
K062998
Distribution
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.

Product description

Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412

Code information (models, lots, serial numbers)

Lot Numbers/UDI 332080 (01)00880304259805(17)270706(10)332080; 671760 (01)00880304259805(17)271026(10)671760; 752810 (01)00880304259805(17)270725(10)752810; 856940 (01)00880304259805(17)271030(10)856940; 930700 (01)00880304259805(17)270816(10)930700

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

15 devices cleared under K062998 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 93323).

Sources and updates

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