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.
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 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…
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 21,675
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · DePuy Orthopaedics, Inc.
See all →- HighATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
FDA (Devices) · 2024-04-10
- HighAttune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure
FDA (Devices) · 2023-03-29
- HighDePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
- HighOrthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
FDA (Devices) · 2023-03-29
- HighOrthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
Same hazard · foreign object retention
See all →- SevereStryker Trevo XP ProVue Retriever Recalled for Core Wire Fracture
FDA (Devices) · 2020-10-28
- SevereEv3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk
FDA (Devices) · 2020-04-01
- HighMedline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk
FDA (Devices) · 2019-08-14
- SevereFDA Recalls Covidien Emprint Percutaneous Ablation Antenna Due to Tip Disengagement
FDA (Devices) · 2018-12-26
- SevereFDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement
FDA (Devices) · 2018-12-26
Similar recalls
- HighDePuy Glenosphere Orientation Guide Recalled for Incorrect Etched Arrow Placement
FDA (Devices) · 2013-06-19
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
- HighStryker Blueprint Glenoid Pin Guide May Disassemble During Shoulder Surgery
FDA (Devices) · 2025-01-22
- HighDePuy Charnley Pin Retractor and Handle Set Recalled for Component Breakage
FDA (Devices) · 2014-10-15
- HighDePuy Mitek surgical anchor inserter tip may fragment and be retained
FDA (Devices) · 2023-06-14
- SevereDePuy Synthes 10.5mm Reamer Head Recalled for Breakage and Tissue Damage
FDA (Devices) · 2020-12-23