Cathcart Hip Ball prosthesis recalled for missing surgical technique specification
DePuy Orthopaedics is recalling Modular Cathcart Hip Ball prostheses (sizes 41-60mm) because the Instructions for Use and Surgical Technique Guide did not document a +5mm offset specification. Updated guides now clarify this for hemi-hip arthroplasty procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source describes a documentation and specification issue without reporting any injuries or illnesses. This is a Class II device, but the hazard is limited to incomplete documentation that has been corrected with an updated Surgical Technique Guide. This fits the rubric criteria for documentation issues and minor labeling errors.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling Modular Cathcart Fracture Head Hip Ball prostheses, sizes 41mm to 60mm. The recall covers 3,488 units distributed worldwide, including throughout the United States and internationally.
The Cathcart Ball prosthesis has an inherent +5mm offset that was not specified in the device's Instructions for Use or Surgical Technique Guide. This specification is important when using the Cathcart head in hemi-hip arthroplasty procedures. The Surgical Technique Guide has been updated to clarify that the +5mm offset must be taken into consideration during surgical use.
Healthcare providers should consult the updated Surgical Technique Guide when using this device. The recall applies to all lots until the Instructions for Use is revised.
The recalled product
- Product
- MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000…
- Manufacturer
- DePuy Orthopaedics, Inc.
- Category
- Medical Device — Hip Prosthesis
- Hazard
- Affected units
- 3,488
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 (1)
- All lots until Instructions for Use (IFU) is revised
Distribution
Distributed nationwide across the United States.
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