Zimmer Biomet Ceramic Hip Head Recall — Missing Compatibility Labeling
Zimmer, Inc. is recalling the Zimmer Biomet Ceramic Hip Head (Model 802602202) due to inadequate labeling of compatibility information for use with cobalt-chrome or stainless-steel femoral stems.
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 is a medical device labeling deficiency involving missing compatibility information. Inadequate labeling could result in incompatible component pairing during hip replacement surgery. No illnesses or injuries have been reported, placing this at Score 3 per the rubric.
Plain-English summary
Zimmer, Inc. is recalling 416 units of the Zimmer Biomet Ceramic Head (22.2 mm Diameter, 12/14 Taper, +0 Neck, Model 802602202). The product labeling does not adequately provide compatibility information for use of the ceramic femoral heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
The affected devices have GTIN 00887868376320 and were distributed with Instruction For Use (IFU) document 87-6204-051-99 Rev D or earlier versions. Worldwide distribution included the United States, Panama, Hong Kong, and China.
The recalled product
- Product
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
- Manufacturer
- Zimmer, Inc.
- Category
- Medical Device — Hip Implant
- Hazard
- incomplete-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 00887868376320
- All lots distributed with IFU 87-6204-051-99 Rev D or prior
Distribution
Distributed nationwide across the United States.
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