Howmedica Osteonics Corp. Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Brand
Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
which with expiration date on/after October 28, 2021
Products Sold
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
Howmedica Osteonics Corp. is recalling Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in due to Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026