Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or no
Summary
The FDA issued a Class II for Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in t by Zimmer GmbH. Reason: 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.
Details
Source
Device Recall
External ID
Z-3132-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
Lot/Code Info: UDI: (01)00887868271489(17)331130(10)3185263 Lot Number: 3185263
Quantity Affected: 69 units
Reason for Recall
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
Distribution
Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-08
Company
Winterthur
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zimmer GmbH has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zimmer GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zimmer GmbH have FDA actions?
Zimmer GmbH has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3132-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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