Stryker Laparoscopic Fixation Clamp Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic fixation clamps because the instructions for use do not support specific sterilization methods.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a documentation issue regarding sterilization instructions, which fits the rubric for moderate severity involving minor labeling or documentation errors.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the PKG, FIXATION CLAMP 5MM WITH RATCHET (P/N 0250080130). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The devices are distributed worldwide, including in the United States and numerous international locations.
The recall is due to a documentation issue in the Instructions for Use (IFU 1000-401-070 Revision G or prior). The parameters provided in these instructions do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. This means the provided documentation does not adequately cover these specific sterilization processes for the device.
Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 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 w
- Manufacturer
- Stryker Endoscopy
- Affected units
- 180,573
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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