Z-0240-2023Class II

Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010

Name: Z-0240-2023 Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
Creator: Howmedica Osteonics Corp.
Published: 2022-10-21
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2022-10-21 / Open, Classified

FDA source

Howmedica Osteonics Corp. began a recall of Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010 on 2022-10-21. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0240-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-21
Posted: 2022-11-15
Recalling firm: Howmedica Osteonics Corp
Product: Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
Product code: MBB Bone Cement, Antibiotic
Reason for recall: 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: Under Investigation by firm
Action: 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]
Quantity in commerce: 90 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI: (01)14260056885768(17)231130(10)145BB909GC Lot Number: 202BB943KC Exp. Date: 30/Sep/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0240-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0240-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-15

Product code MBB

K123081Class IIBonos R Genta 1X20 Model 01-0228; Bonos R Genta 2X20 Model 01-0229; Bonos R Genta 1X40 Model 01-0217; Bonos R Genta 2X40Aap Biomaterials GmbH & Co. KG / cleared 2013-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)