DePuy Synthes Hip Prosthesis Recall Due to Incorrect Size Labeling
DePuy Orthopaedics recalled 50 hip prostheses with incorrect part numbers and sizes etched on the devices. The affected Lot D20111130 was distributed domestically and to Bermuda.
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 3/5 (High).
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 Class II medical device recall involving mislabeled hip prostheses (incorrect part number and size etched). While no injuries have been reported, this qualifies as a risk-of-harm product where implanting the wrong size prosthesis could cause adverse health consequences during surgery.
Plain-English summary
DePuy Orthopaedics recalled 50 units of Articul/eze Femoral Head hip prostheses due to incorrect part numbers and sizes etched on the devices. All affected units were from Lot D20111130.
The defect involves the labeling on the prosthesis: the part number and size etched on the device do not match the actual product specifications. This discrepancy could create confusion during surgical implantation if healthcare providers rely on the marked information rather than verifying against manufacturer documentation.
The recalled devices were distributed domestically to 20 states including California, Connecticut, Florida, Georgia, Iowa, Indiana, Louisiana, Maine, Minnesota, Missouri, Montana, North Carolina, Nebraska, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, and Wisconsin, as well as internationally to Bermuda.
Affected healthcare providers and hospitals should verify the actual specifications of devices from this lot against manufacturer documentation. Contact DePuy Orthopaedics to confirm the correct part numbers and sizes before implantation.
The recalled product
- Product
- DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
- Manufacturer
- DePuy Orthopaedics, Inc.
- Category
- Medical Device — Hip Prosthesis
- Affected units
- 50
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)
- Lot: D20111130 GTIN: 10603295033172
Distribution
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