PlainRecalls
FDA Devices Moderate Class II Terminated

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 cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+, GLOBAL STEPTECH APG, and DELTA XTEND Systems. The guide pin

Reported: April 16, 2014 Initiated: March 28, 2014 #Z-1437-2014

Product Description

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 cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+, GLOBAL STEPTECH APG, and DELTA XTEND Systems. The guide pin is scored in three locations, which allows the surgeon to select a desired pin length. The single-use shoulder instrument is made from 316L Stainless Steel.

Reason for Recall

Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patient.

Details

Recalling Firm
DePuy Orthopaedics, Inc.
Units Affected
21,675
Distribution
USA Nationwide Distribution including Canada
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
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 cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+, GLOBAL STEPTECH APG, and DELTA XTEND Systems. The guide pin is scored in three locations, which allows the surgeon to select a desired pin length. The single-use shoulder instrument is made from 316L Stainless Steel.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 21,675.
Why was this product recalled? ▼
Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 16, 2014. Severity: Moderate. Recall number: Z-1437-2014.

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