FDA Device Intelligence
Home › Howmedica Osteonics Corp. › Orthinox

Orthinox

Howmedica Osteonics Corp. · Model 6364-2-030 · UDI-DI 04546540273284

KWZKWLLWJMEHKWYJDILZOMBLMAYLPH Prescription
10
510(k) clearances
5,692
Adverse events (21 deaths)
20
Recalls
157
Facilities

Description

V40 Femoral head

Recalls

DateFirmReason
2026-07-30Howmedica Osteonics Corp.Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o
2023-11-21Exactech, Inc.Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
2022-08-11Exactech, Inc.Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
2022-08-11Exactech, Inc.Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
2018-09-21Encore Medical, LpComplaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, d
2015-05-06Smith & Nephew, Inc.The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
2015-05-06Smith & Nephew, Inc.The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
2015-05-06Smith & Nephew, Inc.The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
2015-05-06Smith & Nephew, Inc.The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
2015-05-06Smith & Nephew, Inc.The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.

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 docs
Data 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.