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.
What this means for you
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, knee,
- 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
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