510(k) K160071 ยท MBB Bone Cement, Antibiotic
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 16, 2016 |
| Received | Jan 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160071
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406. Terminated |
KWS | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408. Terminated |
KWS | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410. Terminated |
KWS | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412. Terminated |
KWS | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414. Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.