Home / Recalls / Biomet, Inc. / Z-2156-2020

Z-2156-2020 Class II Terminated

Recalled by Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
June 3, 2020
Initiation Date
April 17, 2020
Termination Date
June 25, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis

Reason for Recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

Code Information

Lot Number/UDI: 735550 (01)00841036226534(17)220111(10)735550

Other recalls by Biomet, Inc.

  • Z-0212-2026 Class II — BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: (September 23, 2025)
  • Z-2619-2025 Class II — Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 (September 9, 2025)
  • Z-0477-2025 Class II — JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 (October 21, 2024)
  • Z-2179-2024 Class II — RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip h (May 17, 2024)
  • Z-1607-2024 Class II — Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number (March 13, 2024)
  • Z-0569-2024 Class II — Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 (November 2, 2023)
  • Z-0570-2024 Class II — Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 (November 2, 2023)
  • Z-0373-2024 Class II — Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuc (October 9, 2023)
  • Z-0375-2024 Class II — Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuc (October 9, 2023)
  • Z-0385-2024 Class II — Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccess (October 9, 2023)