Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
This recall has been terminated (originally issued March 19, 2018).
- Company
- Synthes, Inc.
- Recall Initiated
- March 19, 2018
- Terminated
- April 11, 2019
- Recall Number
- Z-1514-2018
- Quantity
- 31
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for the connection screw of the stem extractor to break.
Distribution
Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.
Lot / Code Info
09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949
Root Cause
Device Design
Action Taken
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: Synthes3091@stericycle.com . 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.