Stryker Endoscopy Recalls 8mm Trocars Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of 8mm trocars because the instructions for use do not support specific sterilization methods.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it is a documentation issue regarding sterilization instructions, which falls under the rubric criteria for packaging or documentation-only problems without reported injuries.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, TROCAR, 8MM, PYRAMIDAL TIP (P/N 0250080155). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The devices are distributed worldwide, including nationwide in the United States and in numerous international locations.
The recall was initiated because the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. This documentation issue affects the ability to properly sterilize the devices using these specific methods.
The affected units are identified by the following codes: 23479, 29896, 43217, 44559, 75716, 77193, 81337, and 84536. Healthcare facilities and distributors should stop using the affected devices and contact Stryker Endoscopy for further instructions regarding the recall.
The recalled product
- Product
- PKG, TROCAR, 8MM, PYRAMIDAL TIP, P/N 0250080155. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports wh
- Manufacturer
- Stryker Endoscopy
- Hazard
- Affected units
- 180,573
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 (1)
- 23479 29896 43217 44559 75716 77193 81337 84536
Distribution
Part of a larger recall action
This product is one of 207 recalled by Stryker Endoscopy 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.
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