DePuy Glenosphere Orientation Guide Recalled for Incorrect Etched Arrow Placement
DePuy Orthopaedics is recalling Glenosphere orientation guides because an etched arrow is on the wrong side, which could lead to incorrect implant alignment.
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 involves a medical device where a defect could lead to incorrect implant orientation, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 20 units of the Glenosphere orientation guide used with the Delta XTEND Reverse Shoulder system. The recall is due to an arrow etched on the instrument being incorrectly placed on the opposite side of the tool. This instrument is used in reverse shoulder arthroplasty to properly align the glenosphere implant.
The affected units are identified by Part Number 230795000 and Lot Number 5120443. The products were distributed worldwide, including in the United States, Australia, Canada, the Czech Republic, England, Germany, Switzerland, and Turkey.
Using the improperly etched arrow as a guide could potentially lead to incorrect orientation of the glenosphere implant. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 20
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)
- Part Number 230795000/Lot Number 5120443
Distribution
Distributed nationwide across the United States.
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