FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
- Recall number
- Z-0734-2019
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
- Status
- Terminated
- Initiated
- 2018-11-28
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- There is a potential for silicone shedding during cleaning and sterilization.
- Root cause
- Process control
- Action
- Urgent Medical Device Correction notification letters dated 11/28/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken.
- Quantity
- 971 i nTotal
- Distribution
- Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
- Lot, serial or model codes
- Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512868
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSM
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28