Lower riskMedical device recall · FDA · Published August 8, 2024
Zimmer Biolox Option Taper Sleeve Recall: Mislabeled Product in Packaging
Zimmer recalls Biolox Option Taper Sleeves due to mislabeled packaging. The outer box lists a standard neck sleeve but contains a -6mm neck sleeve. This mismatch could lead to improper surgical use.
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
“Zimmer Biolox Option Taper Sleeve Recall: Mislabeled Product in Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54250-zimmer-biolox-option-taper-sleeve-recall-mislabeled-product-in-packaging. Based on FDA recall #Z-3133-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3133-2024%22&limit=1).
The FDA announced on Aug. 8, 2024, that Zimmer GmbH is recalling Biolox Option Taper Sleeves due to mislabeled packaging containing incorrect neck sizes. This Class II recall affects 58 units distributed worldwide.
How to tell if you have it
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck
UPC 00887868271465
The hazard
The outer packaging is labeled as a standard neck sleeve while the product inside is a -6mm neck sleeve, and vice versa. The FDA stated that the correct neck size can be identified by the device etching as either STD or -6.
Context
GovInfoNow's records show Zimmer GmbH has issued six other recalls since Feb. 28, 2018. Previous issues include a May 7, 2021 recall of the Natural Nail System for potential commingling and an Aug. 21, 2019 Sidus Shoulder Implant recall for incorrect labeling. Other recent recalls of similar products include the Feb. 16, 2026 Encore Medical EMPOWR 3D Knee Ins 11L 14MM VE Packaging Mix-Up Recall and the Jan. 5, 2026 Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall.
How to tell if you have this one
Check the outer packaging label for a standard neck sleeve description. The product inside the box is a -6mm neck sleeve, identifiable by the device etching as either STD or -6. The item number is 650-1064 and lot number 3185266.
Brand
Zimmer
Product
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.
Recall number
Product, codes & lots
Quantity
Z-3132-2024
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; UDI: (01)00887868271489(17)331130(10)3185263 Lot Number: 3185263
69 units
Z-3133-2024
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064; UDI: (01)00887868271465(17)331130(10)3185266 Lot Number: 3185266
58 units
Based on the official FDA remedy
What to do — step by step
Check Packaging Label
Look for the outer box label that says 'standard neck sleeve' but contains a -6mm neck sleeve.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3133-2024 (August 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3133-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.