Howmedica Recalls 15 Pouches of Sterile Knee Instruments Due to Barrier Risk
Howmedica Osteonics Corp. is recalling 15 pouches of sterile knee instruments because the outer sterile barrier may be compromised.
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: The recall involves a potential compromise of the sterile barrier for surgical instruments, which poses a risk of infection (risk-of-harm product) but no injuries or illnesses have been reported in the source text.
Plain-English summary
Howmedica Osteonics Corp. is recalling 15 pouches of Sterile Knee Instruments Disposable Fluted Headless Pins, REF 7650-2038A. The recall is due to a potential for the outer pouch sterile barrier to be compromised.
The affected products are manual surgical instruments intended for use during hip, knee, shoulder, elbow, or wrist arthroplasty, or trauma surgeries. The specific lot number is SC22130X, with an expiration date of 2023-08-05.
The products were distributed in the United States in the states of Alabama, Florida, Illinois, Michigan, New Jersey, and Ohio. Healthcare facilities should stop using the affected products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip…
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot SC22130X Exp 2023-08-05
Distribution
Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- SevereHowmedica Recalls Scorpio Patella Implants Due to Polyethylene Wear Risk
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Scorpio Receded Metal Backed Patella Implants
FDA (Devices) · 2026-09-23
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighHip Arthroplasty Surgical Instruments Recalled for Sterile Barrier Failure
FDA (Devices) · 2024-02-14
- ModerateHowmedica Recalls Six Knee Prosthesis Units Due to Incorrect Size Labeling
FDA (Devices) · 2018-05-02
- HighSurgical hip instruments recalled due to compromised sterility packaging
FDA (Devices) · 2024-02-14
- ModerateHowmedica Recalls Accolade and Restoration Hip Products Due to Barrier Defects
FDA (Devices) · 2018-03-21
- HighStryker Recalls Wrist Implants Due to Potential Sterile Barrier Compromise
FDA (Devices) · 2015-08-26
- HighStryker Howmedica Command Instrument Broach Handle Recalled for Fracture Risk
FDA (Devices) · 2013-03-20