—#197038

Product

Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001

FDA product code: LOD — Bone Cement
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K014199
Affected lot / code info: UDI# P/N 6197-1-001 (01)07613327128741 (17)230331(10)lot# GTIN: 07613327128741-Instructions for Use (IFU) received with product: 0700-7-012 (IFU Radiopaque Bone Cement) All lots manufactured under Rev AB, which with expiration date on/after October 28, 2021

Why it was recalled

Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Update 12/15/22: An UPDATED Urgent Medical Device Correction PFA 3140774 was issued to impacted customers in Turkey only on December 15, 2022. Letter states: 1. Please inform users of this UPDATE Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware. 2. Go to link https://ifu.stryker.com/ and follow instructions for Figures 1 and 2 for the electronic version of the Turkish translated Instructions for Use for affected product outlined in Table 1. 3. Complete and sign the enclosed UPDATE Urgent Medical Device Correction Business Reply Form. Potential Harm: There are no identified harms associated with this issue which would lead to any known adverse health consequences. Please assist us in meeting our regulatory obligation by emailing back the attached UPDATE Urgent Medical Device Correction Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com. ____________________________________________________________________________ Stryker issued Urgent Medical Device Correction PFA 3140774 to customers in Turkey only via Stryker sales representatives on Nov. 16, 2022. Letter states reason for recall and action to take: 1. Please inform users of this Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware. 2. Go to link https://ifu.stryker.com/ and follow instructions for Figures 1 and 2 for the electronic version of the Turkish translated Instructions for Use for affected product outlined in Table 1. 3. Complete and sign the enclosed Urgent Medical Device Correction Business Reply Form.

Recalling firm

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

Distribution

Distribution pattern: International distribution in the country of Turkey.

Timeline

Recall initiated: 2022-11-07
Posted by FDA: 2022-12-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197038. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.