Recall Z-1838-2014 ยท PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
Biomet, Inc.
G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
| Date | Jun 19, 2014 (initiated May 7, 2014) |
| Status | Terminated |
| Reason | Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. |
| Root cause | Use error |
| Action | The firm issued the following notice on May 7, 2014: URGENT MEDICAL DEVICE RECALL NOTICE: This notification is to inform you of an Urgent Medical Device Recall initiated by Biomet Orthopedics ("Biomet") which involves Part Numbers: 110003458 G7 Positioning Guide Rod and 110003500 G7 Positioning Guide Post. These instruments have been consigned and/or invoiced to your account. Biomet has initiated this action following an investigation which identified that positioning guide rod may fracture during impaction of the acetabula shell. If the positioning guide rod fractures, then the positioning g |
| Quantity | 1047 total |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121874 | G7 ACETABULAR SYSTEM Biomet Manufacturing Corp, Nov 23, 2012 |