[pending] Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, H
Pending LLM rewrite. Source: FDA_DEVICE Z-1649-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
The recalled product
- Product
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
- Manufacturer
- Zimmer, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN 00887868376368
- All lots distributed with IFU 87-6204-051-99 Rev D or prior
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- ModerateSilastic Brand Foley Catheters recalled due to surface stain
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27