The Recall Desk
HighFDA (Devices)·Z-0452-2016·Announced 2015-12-30

Zimmer Universal Power System Handpieces Recalled for Malfunction

Zimmer, Inc. is recalling 87 Universal Power System handpieces because a malfunction could cause them to start unexpectedly when connected to a power source.

What this means for you

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 unexpected activation and injury, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer, Inc. is recalling 87 units of the Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. The affected units are prescription-only devices manufactured in Switzerland. The recall covers Model # 01-8507-400-00 and Model # 89-8507-400-00.

The recall was initiated because the firm identified a malfunction that made it possible for the handpiece to start by itself when the power source is connected. This unexpected activation poses a risk of injury to patients or healthcare providers during use.

The affected products 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. Healthcare providers and consumers who possess these specific model numbers should stop using the devices immediately and contact Zimmer, Inc. for instructions on return or replacement.

The recalled product

Product
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
Manufacturer
Zimmer, Inc.
Category
Medical Device — Surgical Handpiece
Hazard
Affected units
87

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 # 01-8507-400-00 & Model # 89-8507-400-00

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 →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · unexpected activation

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