The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0973-2019·Announced 2019-03-13

Stryker Reprocessed Arthroscopic Shavers Recalled for Display and Function Errors

Stryker is recalling 14,265 reprocessed arthroscopic shavers that may display incorrect settings or error messages, preventing proper use during surgery.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device that may not function correctly during surgery, posing a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Stryker Sustainability Solutions is recalling 14,265 units of reprocessed arthroscopic shavers. These devices are used in orthopedic surgeries to cut, abrade, and remove tissue and bone. The recall covers specific catalog numbers and lots distributed nationwide in the United States, as well as in Israel and Canada.

The recall is due to a defect where affected shavers may display the incorrect catalog number and speed settings when connected to the generator. Additionally, the devices may require manual mode for use on CORE generators or display an error message on Crossfire 1 and 2 generators that prevents the device from being used. These issues could interfere with the proper operation of the surgical instrument.

Healthcare facilities and users should stop using the affected units immediately. Stryker Sustainability Solutions is the recalling firm responsible for managing the recall. Users should verify their device catalog numbers and lot numbers against the list provided in the official recall notice to determine if their units are affected.

The recalled product

Product
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended…
Manufacturer
Stryker Sustainability Solutions
Category
Medical Device — Surgical Instrument
Hazard
Affected units
14,265

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 (12)

  • Catalog Numbers: 375-450-000 375-940-000
  • 375-532-000 375-940-012
  • 375-534-000 375-941-000
  • 375-542-000 375-941-012
  • 375-544-000 375-941-500
  • 375-545-000 375-950-000
  • 375-548-000 375-950-012
  • 375-552-000 375-950-112
  • 375-554-000 375-951-000
  • 375-555-000 375-951-012
  • 375-562-000 375-951-100
  • 375-564-000 375-951-112

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

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