Z-0737-2023Class III

Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in...

Name: Z-0737-2023 Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in...
Creator: Howmedica Osteonics Corp.
Published: 2022-11-07
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2022-11-07 / Open, Classified / root cause: labeling and UDI

FDA source

Howmedica Osteonics Corp. began a recall of Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001 on 2022-11-07. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0737-2023
Classification: Class III
Status: Open, Classified
Initiated: 2022-11-07
Posted: 2022-12-20
Recalling firm: Howmedica Osteonics Corp
Product: Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Product code: LOD Bone Cement
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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 [email protected]. ____________________________________________________________________________ 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.
Quantity in commerce: 20 units
Distribution: International distribution in the country of Turkey.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0737-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0736-2023	Class III	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-20
Z-0737-2023	Class III	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-20

Product code LOD

K014199Class IISurgical Simplex P with TobramycinHowmedica Osteonics Corp. / cleared 2003-05-06

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)