—#196583

Product

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

FDA product code: MBB — Bone Cement, Antibiotic
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K123081
Affected lot / code info: UDI: (01)14260056885768(17)231130(10)145BB909GC Lot Number: 202BB943KC Exp. Date: 30/Sep/2024

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)

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2022-10-21
Posted by FDA: 2022-11-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196583. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.