DePuy Pinnacle Hip Cups Recalled for Potential Cross-Threaded Apex HE Fixation
DePuy Orthopaedics is recalling Pinnacle Hip Cups because the Apex HE screw may thread through the cup shell without stopping, potentially protruding internally.
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: The recall is classified as FDA Class II, and the source text describes a mechanical defect in an implanted medical device that could lead to internal protrusion, representing a risk of harm where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling certain Pinnacle Cup devices, which are part of the Pinnacle Hip Solution for anatomic reconstruction of the hip joint. The recall involves 14,161 lots, with 10 units per lot, distributed worldwide and nationwide in the US.
The recall is issued because certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter." This defect could lead the Apex HE screw to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-threading." If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.
Patients who have had Pinnacle Hip Cups implanted should contact their healthcare provider to discuss the recall and determine if any action is necessary. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
The recalled product
- Product
- Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054…
- Manufacturer
- DePuy Orthopaedics, Inc.
Distribution
Distributed nationwide across the United States.
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