Z-1042-2023 Class II Ongoing
FDA device recall Z-1042-2023 was initiated by Biomet, Inc. on Dec 29, 2022 and is designated Class II. Reason for recall: Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). The recall status is ongoing. Affected quantity: 157 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 8, 2023
- Initiation Date
- Dec 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 157 units
Product Description
(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112
Reason for Recall
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Distribution Pattern
International distribution to the countries of: Argentina, China, Costa Rica, India, Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand. Expanded Recall US states of: FL, IN, MD, OH, PA, WI
Code Information
(1) UDI: (01)00880304270770(17)320408(10)J7209534 Lot Number: J7209534 Expanded Recall: Lot Numbers/UDI: J7197497 (01)00880304270770(17)320504(10)J7197497, J7215873 (01)00880304270770(17)320428(10)J7215873, J7220365 (01)00880304270770(17)320504(10)J7220365, J7220368 (01)00880304270770(17)320504(10)J7220368. (2) Lot Numbers/UDI: J7133633 (01)00880304270787(17)320504(10)J7133633; J7175232 (01)00880304270787(17)320504(10)J7175232. (3) Lot Number/UDI: J7173881 (01)00880304270794(17)320504(10)J7173881; (4) Lot Number/UDI: J7220405 (01)00880304270080(17)320504(10)J7220405. (5) Lot Number /UDI: J7215860 (01)00880304270817(17)320505(10)J7215860.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1042-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026