This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Archived

This page has been archived on the Web.

Health product recall

Various Zimmer Biomet Polyethylene Implants (2017-02-22)

Starting date:
February 2, 2017
Posting date:
February 23, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-62566

Affected Products

  1. Bio Plug Intramedullary Canal Plugs
  2. Ringloc Bipolar Acetabular Component
  3. Maxim Knee System-Primary Tibial Tray
  4. Maxim Knee System-Stemmed Tibial Tray Component
  5. Arcom Ringloc Acetabular Liner
  6. Vanguard Total Knee System - DCM - CR Tibial Bear
  7. Vanguard Total Knee System - DCM - CR Lip Tibial
  8. Vanguard Total Knee System - DCM - PS Tibial Bear
  9. Vanguard Total Knee System - DCM - PS Plus Tibial
  10. Series A Patella Components 1 Peg w/ Wire
  11. Series A Patella Components 3 Peg
  12. Arcomxl Ringloc Liner
  13. Arcomxl Max-Rom Ringloc Liner
  14. Vanguard Total Knee System - Posterior Stabilized
  15. Total Knee System - Anterior Stabilized Bearings
  16. Vanguard E-Poly Cruciate Retaining Tibial Bearing
  17. Vanguard E-Poly Posterior Stabilized Tibial Bearing
  18. Vanguard E-Poly Anterior Stabilized Tibial Bearing
  19. OSS - Tibial Components
  20. OSS - Screws and Pins
  21. E1 Ringloc Max-Rom Acetabular Liner
  22. E1 Ringloc 10 Degree Acetabular Liner
  23. E1 Ringloc Hi-Wall Acetabular Liner
  24. E1 Ringloc +3 Hi-Wall Acetabular Liner
  25. Hybrid Glenoid Base
  26. Comprehensive Reverse Shoulder - Humeral Bearing

Reason

Zimmer Biomet is conducting a lot specific medical device field action for various polyethylene and ceramic implants. The affected products are being removed due to the potential presence of elevated endotoxin levels that exceed the specification limit. The issue was discovered during routine bacterial endotoxin testing (BET). There have been no complaints received, related to this issue. Endotoxins (pyrogens) are substances found in certain bacteria. The FDA-adopted standard for endotoxin levels is 20 EU/device. There were three samples during an approximate 6 week period that were found to exceed this level. As a result, the devices manufactured during this period are being removed.

Affected products

A. Bio Plug Intramedullary Canal Plugs

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 163005
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


B. Ringloc Bipolar Acetabular Component

Lot or serial number

More than 10 numbers contact manufacturer

Model or catalog number
  • 11-165222
  • 11-165226
  • 11-165232
  • 11-165236
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


C. Maxim Knee System-Primary Tibial Tray

Lot or serial number

More than 10 numbers contact manufacturer

Model or catalog number
  • 141261
  • 141263
  • 141264
  • 141265
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


D. Maxim Knee System-Stemmed Tibial Tray Component

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 141514
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


E. Arcom Ringloc Acetabular Liner

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 11-105902
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


F. Vanguard Total Knee System - DCM - CR Tibial Bear

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 183421
  • 183422
  • 183424
  • 183440
  • 183442
  • 183464
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


G. Vanguard Total Knee System - DCM - CR Lip Tibial

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 183520
  • 183522
  • 183540
  • 183542
  • 183560
  • 183562
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


H. Vanguard Total Knee System - DCM - PS Tibial Bear

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 183620
  • 183622
  • 183640
  • 183646
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


I. Vanguard Total Knee System - DCM - PS Plus Tibial

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 183726
  • 183740
  • 183742
  • 183744
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


J. Series A Patella Components 1 Peg w/ Wire

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 184700
  • 184702
  • 184720
  • 184724
  • 184726
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


K. Series A Patella Components 3 Peg

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 184760
  • 184762
  • 184766
  • 184768
  • 184780
  • 184782
  • 184784
  • 184788
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


L. Arcomxl Ringloc Liner

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 184760
  • 184762
  • 184766
  • 184768
  • 184780
  • 184782
  • 184784
  • 184788
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


M. Arcomxl Max-Rom Ringloc Liner

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • XL-105933
  • XL-105934
  • XL-105994
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


N. Vanguard Total Knee System - Posterior Stabilized

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 189420
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


O. Total Knee System - Anterior Stabilized Bearings

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 189020
  • 189040
  • 189062
  • 189080
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


P. Vanguard E-Poly Cruciate Retaining Tibial Bearing

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • EP-183424
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


Q. Vanguard E-Poly Posterior Stabilized Tibial Bearing

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • EP-183640
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


R. Vanguard E-Poly Anterior Stabilized Tibial Bearing

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • EP-189040
  • EP-189060
  • EP-189062
  • EP-189080
  • EP-189100
  • EP-189104
  • EP-189120
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


S. OSS - Tibial Components

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 150414
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


T. OSS - Screws and Pins

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 150477
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


U. E1 Ringloc Max-Rom Acetabular Liner

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • EP-105933
  • EP-105934
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


V. E1 Ringloc 10 Degree Acetabular Liner

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • EP-105894
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


W. E1 Ringloc Hi-Wall Acetabular Liner

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • EP-105923
  • EP-105925
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


X. E1 Ringloc +3 Hi-Wall Acetabular Liner

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • EP-108322
  • EP-108323
  • EP-108525
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


Y. Hybrid Glenoid Base

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 113952
  • 113954
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


Z. Comprehensive Reverse Shoulder - Humeral Bearing

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • XL-115363
  • XL-115364
  • XL-115366
  • XL-115367
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


Report a problem or mistake on this page
What was wrong?

If you want to receive a follow-up reply, please include your name and e-mail address.

CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Date modified: