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Terminated

Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.

FDA Recall Z-1514-2018 · Posted None

Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeHWB
Date Initiated2018-03-19
Date Terminated2019-04-11
Product Quantity31

Reason for Recall

There is a potential for the connection screw of the stem extractor to break.

Firm Action

The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTICE" dated 3/19/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to the following: Review the instructions listed in this notification. Forward this notice to anyone in your facility that needs to be informed. If any of the affected product has been forwarded to another facility, contact that facility. Keep a copy of this notice. Return the Verification Section (page 3 of this letter) to Synthes by: o Fax: 1-888-731-7954 or o Scan/email: [email protected] . Follow the Instructions if connecting screw for the stem extractor breaks If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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