Recall Z-1514-2018 ยท HWB Extractor
Synthes, Inc.
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
| Date | Mar 19, 2018 |
| Status | Terminated |
| 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.c |
| Quantity | 31 |
| Distribution | Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.