The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1834-2015·Announced 2015-07-01

Stryker Recalls Fios First Entry Trocars Due to Fracture Risk

Stryker is recalling Fios First Entry trocars because some may fracture at the distal tip, leaving fragments at the surgical site.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fracture) that results in fragments at the surgical site, which aligns with the rubric criteria for Severe severity involving significant injury or structural defects.

Plain-English summary

Stryker Sustainability Solutions is recalling Fios First Entry trocars, specifically the 5mm x 100mm and 12mm x 100mm models (CTF03 and CTF73). These medical devices are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures, including thoracic, gynecologic laparoscopy, and other abdominal procedures.

The recall was initiated because Stryker received reports indicating that some of the trocars may fracture at the distal tip. This defect can result in fragments remaining at the surgical site. A total of 147,351 units were distributed nationwide, including Puerto Rico.

Healthcare providers and patients should check their inventory and medical records for the specific lot codes listed in the official recall notice. If a patient has undergone surgery using these devices, they should contact their healthcare provider to discuss the potential risk of retained fragments.

The recalled product

Product
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…
Manufacturer
Stryker Sustainability Solutions
Category
Medical Device — Surgical Instruments
Hazard
Affected units
147,351

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot Codes for Model CTF03: 314326
  • 362394
  • 365229
  • 401076
  • 413450
  • 420581
  • 420607
  • 420609
  • 428106
  • 428114
  • 429863
  • 429866
  • 456224
  • 456242
  • 459592
  • 459597
  • 459617
  • 459954
  • 461862
  • 464282

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Stryker Sustainability Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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