The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0453-2016·Announced 2015-12-30

Zimmer Universal Power System Handpieces Recalled for Malfunction

Zimmer, Inc. is recalling 89 Universal Power System handpieces that may start by themselves when the power source is connected.

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 involves a medical device with a malfunction that could cause unintended activation, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Zimmer, Inc. is recalling 89 units of the UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. The affected models are 01-8507-400-10 and 89-8507-400-10. These prescription-only devices were manufactured in Switzerland.

The recall was initiated because the firm identified a malfunction that makes it possible for the handpiece to start by itself when the power source is connected. This defect poses a risk of unintended activation during use.

The recalled units were distributed in the United States to the states of AR, CA, CO, CT, FL, GA, HI, IL, KS, KY, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, WV, and WY. Users should stop using the affected handpieces and contact Zimmer, Inc. for instructions on repair or replacement.

The recalled product

Product
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
Manufacturer
Zimmer, Inc.
Category
Medical Device — Surgical Handpiece
Hazard
Affected units
89

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)

  • Model # 01-8507-400-10 & Model # 89-8507-400-10

Distribution

Distributed in 32 states:

Part of a larger recall action

This product is one of 2 recalled by Zimmer, Inc. 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 2 products in this recall →

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