510(k) K161273 ยท MBB Bone Cement, Antibiotic
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 25, 2017 |
| Received | May 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161273
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160. Terminated |
JWH | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165. Terminated |
JWH | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170. Terminated |
JWH | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175. Terminated |
JWH | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165. Terminated |
JWH | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170. Terminated |
JWH | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175. Terminated |
JWH | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.