Home › BIOMET MICROFIXATION, INC › HTR-PMI
HTR-PMI
BIOMET MICROFIXATION, INC · Model PM617245 · UDI-DI 00841036202002
1
510(k) clearances
240
Adverse events (1 deaths)
5
Recalls
14
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-26 | DSAART LLC | Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. |
| 2014-12-17 | Stryker Craniomaxillofacial Division | Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively |
| 2014-12-17 | Stryker Craniomaxillofacial Division | Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively |
| 2014-12-17 | Stryker Craniomaxillofacial Division | Potential for implant damage, implant cracking off/breaking intra-operatively. |
| 2013-08-30 | Implantech Associates Inc | Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.