Reported Jul 1, 2015 · Terminated
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry…
Stryker Sustainability Solutions
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327
Is this the product you have?
- Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
- Lot codes and dates
- Lot Codes for Model CTF03
377 of 377 codes
314326362394365229401076413450420581420607420609428106428114429863429866456224456242459592459597459617459954461862464282466767467197467198467350467413468306468471468497468498468941469533469538469539469956469960470614471039471048471060471126471721471725471789471895471911471917473040473280473936474004474035474061474338474340474381474482474487474493474940475171
- Lot Codes for CTF73
31801653181358318195931833943183432318596631865373188429318924331920673193604319494131949943198107319823932016613202726320449732045063207156320716032102633210271321436532143773217385321740732206013220849322473532247423227313322732132295413229556323197232319863233272323541532356853237169323744732381173238439324822132741813274524327453032749363275097327728332772963277502327760032783293280207328021132802243291838
- Lot Codes for Model CTF03
- Amount recalled
- 147,351
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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