Zimmer Biomet Ceramic Hip Prosthesis Head Lacks Stem Compatibility Labeling
Zimmer Biomet's ceramic hip prosthesis head (Model 802802202) lacks adequate labeling for compatibility with certain femoral stems, risking improper surgical assembly.
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: This FDA Class II medical device recall involves a labeling deficiency affecting surgical assembly of a hip prosthesis. No injuries or illnesses have been reported, making the hazard theoretical; per the rubric, risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
Zimmer, Inc. is recalling the Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202. This prosthesis component is used in hip replacement surgery. Approximately 158 units were distributed worldwide, including across the United States, Panama, Hong Kong, and China.
The product's labeling does not adequately provide compatibility information for use with cobalt-chrome or stainless-steel femoral stems. This missing information could lead to improper assembly during surgery or confusion about which stem components are compatible with this ceramic head.
Zimmer is notifying healthcare providers and patients of the recall. No injuries or illnesses have been reported in connection with this issue. If you have received this product, contact your healthcare provider or Zimmer directly for guidance on affected units and replacement options.
The recalled product
- Product
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
- Manufacturer
- Zimmer, Inc.
- Category
- Medical Device — Hip Prosthesis
- Hazard
- inadequate-labeling
- device-incompatibility
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 00887868376351
- All lots distributed with IFU 87-6204-051-99 Rev D or prior
Distribution
Distributed nationwide across the United States.
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