Zimmer GmbH 2024-09-18 Health serious FDA
Health · FDA · Recall #FDA-Z-3133-2024
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip… Recall
Issued September 18, 2024 · Zimmer GmbH
In September 2024, Zimmer GmbH recalled the Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
What you should do
- 1 Stop using Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Zimmer GmbH to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Zimmer GmbH
- Category
- Health
- Recall date
- September 18, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.
- Recall number
- FDA-Z-3133-2024
- Made in
- Switzerland
- Issuing agency
- FDA
In context
- Zimmer GmbH has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.