Stryker Myoma Drill Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Myoma Drill instruments because the instructions for use do not support specific sterilization methods.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the specific issue is a documentation error regarding sterilization instructions without reported injuries or illnesses, fitting the criteria for a low-severity documentation issue.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the Myoma Drill 10mm Length 320mm (P/N 0250080134). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The recall covers units distributed worldwide, including the United States and 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 proper sterilization of the devices.
Healthcare providers and facilities that have received these instruments should stop using them and contact Stryker Endoscopy for further instructions on the recall process.
The recalled product
- Product
- PKG, MYOMA DRILL 10MM LENGTH 320MM, P/N 0250080134. 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…
- Manufacturer
- Stryker Endoscopy
- 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)
- 746454 944530 1043332 1044456 1046943 67518 71103
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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