FDA-Device2026-09-23Class IIPROCESSING DEFECT

Howmedica Osteonics hip and knee implant components recalled for premature wear risk

OTHERNationwide distributionMedical devices

What this means

Howmedica Osteonics manufactured acetabular (hip socket) and other orthopaedic implant components using polyethylene material that was aged beyond recommended limits. This aging can cause oxidation and increased wear, potentially leading to device fracture, material breakdown, or component separation inside the body.

If you have received one of these implants, contact your surgeon or healthcare provider with your device lot number.
Do not remove or stop using your implant without medical guidance.
Seek immediate care if you experience unusual pain, swelling, or instability in the affected joint.

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Affected count

12,156 US

Manufactured in

325 Corporate Dr, N/A, Mahwah, NJ, United States

Products

ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852 CONSTRAINED ACETABULAR INSERTS 22MM 50MM 2099-2250 CONSTRAINED ACETABULAR INSERTS 22MM 52MM 2099-2252 CONSTRAINED ACETABULAR INSERTS 22MM 56MM 2099-2256 CONSTRAINED ACETABULAR INSERTS 28MM 61MM 2099-2861 EIUS UNI TIB SMALL RM/LL 9MM 6636-0-419 PCA CONST LINER 32MM NEUTRAL C - SHELL 6299-N-332 SYS 12 CONST LINER 32ID 10 DEG P6 +4MM 6302-H-632 TRIDENT 0 DEG CONSTRAINED INSERT 22D 690-00-22D TRIDENT 0 DEG CONSTRAINED INSERT 22E 690-00-22E TRIDENT 0 DEG CONSTRAINED INSERT 28F 690-00-28F TRIDENT 0 DEG CONSTRAINED INSERT 28G 690-00-28G TRIDENT 0 DEG CONSTRAINED INSERT 32I 690-00-32I TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D TRIDENT CONSTR ACET INSERT 690-10-28K TRIDENT CONSTRAINED INSERT 690-10-22E 690-10-22F 690-10-28G 690-10-28H 690-10-28I Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3201-2026

Also reported as

FDA-Device2026-09-23
Howmedica Osteonics orthopaedic implant components recalled for elevated oxidation risk

More Howmedica Osteonics recalls

FDA-Device2026-09-23
Howmedica Osteonics TRIDENT poly insert recalled for premature wear risk
FDA-Device2026-09-23
Howmedica Osteonics OMNIFIT Series I acetabular insert recalled for elevated oxidation and wear risk
FDA-Device2026-09-23
Howmedica Osteonics Scorpio knee implant patella components recalled for oxidation and wear risk

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