Agency classClass IIOur severity:Severe FDA (Devices)·Z-1835-2015·Announced 2015-07-01

Stryker Recalls Optical Access Systems Due to Fracture Risk

Stryker is recalling specific Optical Access Systems 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 is classified as FDA Class II and involves a structural defect (fracture) that leaves foreign fragments at the surgical site, which meets the criteria for a Severe rating due to the potential for significant injury.

Plain-English summary

Stryker Sustainability Solutions is recalling specific models of Optical Access Systems (Trocars) due to reports that the devices may fracture at the distal tip. The affected products are the 5mm x 100mm (Model CTR03) and 12mm x 100mm (Model CTR73) units.

The recall is being conducted because some of these devices have been reported to break, resulting in fragments remaining at the surgical site. The FDA has classified this as a Class II recall. A total of 147,351 units were distributed nationwide, including Puerto Rico.

Healthcare providers should check their inventory for the specific lot codes listed in the official recall notice and stop using the affected devices. Patients who have had surgery using these devices should contact their healthcare provider if they have concerns.

The recalled product

Product: Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. 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…
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 CTR03: 403486
421850
423482
423498
424916 459230
459967
459990
460697
462208
465157
465212
470140
471013
471021
471022
471031
471046
471048
471060
471102

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