The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0593-2016·Announced 2016-01-13

Biomet 3i Dental Impression Copings Recalled for Inadequate Biocompatibility Testing

Biomet 3i is recalling specific dental impression copings due to inadequate biocompatibility testing. The devices are distributed worldwide, including in the US.

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 biocompatibility defect, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Biomet 3i, LLC is recalling specific models of BIOMET 3i Provide Impression Copings. The affected catalog numbers are PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H. These products are intended for use as accessories to endosseous dental implants in the maxilla and mandible.

The recall was initiated because of inadequate biocompatibility testing. The source text does not specify the nature of the biocompatibility failure or report any specific adverse health events or injuries associated with the use of these devices.

A total of 30,111 devices are subject to this recall. The products were distributed worldwide, including nationwide in the United States and in numerous other countries such as Canada, Germany, France, and Australia. Specific lot numbers for each model are listed in the official recall documentation.

The recalled product

Product
BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional…
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implant Accessories
Hazard
Affected units
30,111

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 (20)

  • Model Number: PIC484
  • Lot Numbers: 942680
  • 950198
  • 950706
  • 957203
  • 963249
  • 973436
  • 977567
  • 993384
  • 1004520
  • 1015298
  • 1024240
  • 1034518
  • 1048991
  • 1057119
  • 1095480
  • 1105770
  • 1131300
  • 1133485
  • 1158650

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Biomet 3i, LLC 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 4 products in this recall →

Related recalls

Same manufacturer · Biomet 3i, LLC

See all →

Same hazard · biocompatibility

See all →

Similar recalls