FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
- Recall number
- Z-0240-2023
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
- Status
- Open, Classified
- Initiated
- 2022-10-21
- Posted
- 2022-11-15
- Terminated
- not on file
- Reason
- 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)
- 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: strykerortho5780@sedgwick.com 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 SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Quantity
- 90 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI: (01)14260056885768(17)231130(10)145BB909GC Lot Number: 202BB943KC Exp. Date: 30/Sep/2024
- 510(k) numbers
- K123081
- PMA numbers
- not on file
- Product code
- MBB
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28