Recall Z-3204-2026— Howmedica Osteonics Corp.

Name: FDA recall Z-3204-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-30

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2026-07-30. It names one FDA 510(k) clearance: K983502. Product: TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene). Reason: 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 of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-30
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K983502 — OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEMOsteonics Corp.·cleared 1998-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Reason for recall

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 of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.