Hip Arthroplasty Surgical Instruments Recalled for Sterile Barrier Failure
Howmedica Osteonics Corp. is recalling hip arthroplasty surgical instruments after their sterile packaging failed integrity testing. Units with compromised packaging were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3. This is a risk-of-harm product (sterile surgical instruments) where injury has not yet been reported, placing it at High (3).
Plain-English summary
Howmedica Osteonics Corp. is recalling the HRIS ACET CUP CUT TIP 32X140 (Part Number: 6210-5-200rker), a single-use sterile surgical instrument used during hip arthroplasty procedures.
The recall was initiated after testing revealed that certain units failed to meet acceptance criteria for sterile barrier integrity. The Sterile Barrier Outer Pouch and Protective Barrier Inner Pouch of affected units did not maintain proper integrity, which compromises the product's sterility.
The affected products were distributed worldwide, including throughout the United States and to Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Colombia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, and the United Kingdom. Affected lot numbers are specified in the official recall notice.
Healthcare providers and patients who may have been affected should contact Howmedica Osteonics Corp. or review the recall notice for specific lot numbers. Affected units should not be used for surgical procedures.
The recalled product
- Product
- HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
- Manufacturer
- Howmedica Osteonics Corp.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- ModerateHowmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls Triathlon Universal Baseplate Finishing Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Triathlon Instrument Trays Recalled for Sterilization Dry Time Issue
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls TS Femoral Prep Trays Due to Sterilization Instructions
FDA (Devices) · 2026-10-21
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighHowmedica Recalls 15 Pouches of Sterile Knee Instruments Due to Barrier Risk
FDA (Devices) · 2018-11-14
- ModerateHowmedica Recalls Accolade and Restoration Hip Products Due to Barrier Defects
FDA (Devices) · 2018-03-21
- HighBiomet Recalls Arthroscopes and Implants Due to Sterile Seal Defects
FDA (Devices) · 2016-06-01
- ModerateHowmedica Recalls Accolade and Restoration Hip Products Due to Sealing Defect
FDA (Devices) · 2018-03-21
- ModerateStryker Howmedica Hip Prosthesis Components Recalled for Seal Defects
FDA (Devices) · 2015-05-27
- ModerateHowmedica Recalls Six Knee Prosthesis Units Due to Incorrect Size Labeling
FDA (Devices) · 2018-05-02