DePuy Shoulder Guide Pin Recall Due to Breakage Risk
DePuy Orthopaedics is recalling 21,675 GLOBAL Anchor Peg Glenoid Plus 2.5mm Breakaway Guide Pins because they may break and be left in patients during surgery.
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: The recall involves a risk-of-harm product (foreign object retention) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness or injury.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 21,675 units of the GLOBAL Anchor Peg Glenoid Plus (APG+) 2.5mm Breakaway Guide Pin, Part # 2230-00-019. The product is a single-use, non-sterile instrument made of 316L Stainless Steel used by surgeons to assist in the orientation of cannulated reamers and drills during glenoid surface preparation. The affected units were distributed nationwide in the USA and in Canada.
The recall is being conducted because the guide pin has the possibility of breaking during use and potentially being left in the patient. Urgent Device Correction notifications are being sent to USA distributors, with follow-up communications to surgeons regarding updated surgical techniques to address this risk.
Surgeons and distributors should stop using the affected guide pins and follow the instructions provided in the Urgent Device Correction notifications. Consumers who have had shoulder surgery using this specific instrument should contact their healthcare provider to discuss the recall and any potential implications for their care.
The recalled product
- Product
- GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulat
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 21,675
Distribution
Distributed nationwide across the United States.
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