FDA Medical Device Recalls (openFDA)
Synthes, Inc.: Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
- Recall number
- Z-1514-2018
- Recalling firm
- Synthes, Inc.
- Product
- Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
- Status
- Terminated
- Initiated
- 2018-03-19
- Posted
- not on file
- Terminated
- 2019-04-11
- Reason
- There is a potential for the connection screw of the stem extractor to break.
- Root cause
- Device Design
- 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: 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.
- Quantity
- 31
- Distribution
- Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.
- Lot, serial or model codes
- 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWB
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28