Hallu®- LOCK
NEWDEAL · Model 129730ND · UDI-DI 10381780044987
HTO
Prescription
10
510(k) clearances
29,528
Adverse events (5 deaths)
83
Recalls
361
Facilities
Description
The 20mm phalangeal yellow colored reamer is used to ream the articular surface of the phalanx for maximal contact and ultimate snug-fit of bone ends. Its shape creates a concave cup-shaped phalangeal surface to receive the convex shaped metatarsal surface. It must be used with the same color coded metatarsal reamer to have the same diameter of bone ends.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-24 | Synthes (USA) Products LLC | Products not sterilized, sterility cannot be confirmed |
| 2022-12-07 | Zimmer, Inc. | Two planers were found to be unusable during sawbones shoulder training. |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
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.