Simplex HV bone cement distributed under wrong part number
Howmedica distributed bone cement under incorrect part number 6193-1-010 instead of ordered 6195-1-010. The distribution error affected 90 units shipped nationwide.
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: FDA Class II medical device recall involving distribution of incorrect product part number. The substitution of medical devices presents a potential risk of harm, although no illnesses or injuries have been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling Simplex HV With Gentamicin CE bone cement that was distributed under part number 6193-1-010. Customers who placed orders for part number 6195-1-010 received the wrong part number instead, affecting approximately 90 units distributed nationwide.
The affected product is identified by lot number 202BB943KC with an expiration date of September 30, 2024. The unique device identifier (UDI) is (01)14260056885768(17)231130(10)145BB909GC.
Customers who received this product should verify their order documentation to confirm whether they received the correct part number. Healthcare facilities and customers with the affected lot should contact Howmedica Osteonics Corp. to determine if corrective action or product replacement is necessary.
The recalled product
- Product
- Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- product-substitution
Distribution
Distributed nationwide across the United States.
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