Agency classClass IIOur severity:Severe FDA (Devices)·Z-1836-2015·Announced 2015-07-01

Stryker Recalls Trocars Due to Reported Fracture at Distal Tip

Stryker is recalling specific cannula and seal models because they may fracture at the 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 involves a structural defect in a medical device used during surgery that results in fragments at the surgical site, meeting the criteria for a structural defect or significant injury risk.

Plain-English summary

Stryker Sustainability Solutions is recalling Trocars, specifically the Cannula and Seal models CTS02 and CTS22. These 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 after Stryker received reports indicating that some of the devices may fracture at the distal tip. This failure can result in fragments remaining at the surgical site.

The affected products were distributed nationwide, including Puerto Rico. A total of 147,351 units are involved in this recall. Specific lot codes for both models are listed in the official recall documentation.

The recalled product

Product: Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. 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: fracture
foreign-body
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 CTS02: 362394
420607
428114
429863
459230
459592
459597
459960
459990
461060
461694
465212
466767
467172
468490
469533
469538
469539
469540
469955

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 →

Same manufacturer · Stryker Sustainability Solutions

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Same hazard · fracture