Simplex HV With Gentamicin CE, 10 PACK-Bone cement with… recallZ-0240-2023 · Howmedica Osteonics Corp. · initiated Oct 21, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)
FDA root cause category: Under Investigation by firm
What the company is doing
Stryker issued an An Urgent Medical Device Recall (UMDR) PFA 3082664 Letter issued by Sedgewick on 21/Oct/2022, via UPS 2-day air. Letter states reason for recall, health risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if the device from the affected product table is at your facility. 3. Quarantine and discontinue use of the recalled device identified in the affected product table. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email: [email protected] Fax: (888)-912-7352 5. Please return the devices back to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3082664 6. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement, returns and inventory questions. Please assist us in meeting our regulatory obligation by emailing back the attached Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email [email protected]
Recall details
- Recall number
- Z-0240-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 21, 2022
- Posted by the FDA
- Nov 15, 2022
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 90 units
- Product code
- MBB
- FDA submissions
- K123081
- Distribution
- US Nationwide distribution.
Product description
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
Code information (models, lots, serial numbers)
UDI: (01)14260056885768(17)231130(10)145BB909GC Lot Number: 202BB943KC Exp. Date: 30/Sep/2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Simplex HV with Gentamicin 6195-1-001OSARTIS GmbH · Bone Cement, Antibiotic1 recall64 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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