The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0592-2016·Announced 2016-01-13

Biomet 3i Protection Cap Kits Recalled for Inadequate Biocompatibility Testing

Biomet 3i is recalling 30,111 Protection Cap Kits worldwide due to inadequate biocompatibility testing. The devices are used as accessories for dental implants.

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 involves a risk-of-harm product (medical device) where the specific hazard is inadequate biocompatibility testing, but no injuries or illnesses are reported in the source text.

Plain-English summary

Biomet 3i, LLC is recalling 30,111 units of BIOMET 3i Provide Protection Cap Kits. The affected catalog numbers include PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455. These devices are intended for use as accessories to endosseous dental implants for placement in the maxilla and mandible.

The recall was initiated because of inadequate biocompatibility testing. The agency has classified this recall as Class II. The devices were distributed worldwide, including in the United States (nationwide), Canada, and numerous other countries such as Argentina, Australia, Brazil, China, Germany, and the United Kingdom.

Dental professionals and patients who have received these specific Protection Cap Kits should contact Biomet 3i, LLC for further instructions. The source text does not specify a particular consumer action beyond the standard recall notification process.

The recalled product

Product
BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET…
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implants
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: PAK4140
  • Lot Numbers: 977597
  • 981669
  • 984020
  • 987879
  • 989549
  • 995908
  • 1001595
  • 1004140
  • 1008710
  • 1010960
  • 1014334
  • 1015290
  • 1040122
  • 1040123
  • 1041414
  • 1045559
  • 1051854
  • 1052717
  • 1057786

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 →

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