The Recall Desk
ModerateFDA (Devices)·Z-0685-2017·Announced 2016-12-07

MicroPort Orthopedics Recalls Procotyl Rim-Lock Liners Due to Tissue Reaction Risk

MicroPort Orthopedics is recalling 500 units of Procotyl Rim-Lock Liners because revision rate trends indicate a specific hazard of tissue reaction to metal debris.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. The identified hazard is a suspected tissue reaction based on trend data rather than immediate, widespread acute injury.

Plain-English summary

MicroPort Orthopedics Inc. is recalling 500 units of Procotyl (Rim-Lock) Liners, specifically reference numbers PHA04702, PHA04704, PHA04706, PHA04708, PHA04710, PHA04712, and PHA04714. These liners are designed for use with the Conserve metal head in modular head Metal on Metal Total Hip Arthroplasty (THA) systems. The affected units were distributed worldwide, including in the United States and numerous international markets.

The recall was initiated after an evaluation of revision rate trends within the MicroPort Orthopedics Inc. database showed an increasing overall trend from 2009 to the present. The analysis identified a specific hazard and harm associated with suspected tissue reaction to metal debris for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

Patients who have received these specific implants should contact their healthcare provider to discuss the findings and determine the appropriate course of action. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences, though the identified hazard warrants attention.

The recalled product

Product
Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the conserve metal head
Manufacturer
MicroPort Orthopedics Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
500

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)

  • REF PHA04702 Serial Numbers: PHA04702
  • 087461467
  • 089909592
  • 106368684
  • 106379196
  • 106381827
  • 109949208
  • 129989153
  • 0201018636
  • 0301049040 REF PHA04704 Serial Numbers: 010989155
  • 027373842
  • 038461468
  • 057433172
  • 077453350
  • 089924904
  • 106379197
  • 106380366
  • 106381751
  • 0201018637 REF PHA04706 Serial Numbers: 1414640
  • 010990534

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 recalled by MicroPort Orthopedics 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 7 products in this recall →

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