FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: The 2nd Assist Knee Positioner
- Recall number
- Z-0803-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- The 2nd Assist Knee Positioner
- Status
- Terminated
- Initiated
- 2017-09-07
- Posted
- not on file
- Terminated
- 2018-08-23
- Reason
- Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.
- Root cause
- Package design/selection
- Action
- On September 12, 2017 an URGENT MEDICAL DEVICE RECALL notice was issued to distributors and customers titled "The Second Assistant Disposable Knee Positioner". The notice requests customers to review their inventory and to quarantine any remaining product, which will be returned to the firm. Also, to notify any additional accounts which may have received product from you. Questions or concerns can be directed to Customer Service at 574-371-3071
- Quantity
- 38,879 units
- Distribution
- Nationally
- Lot, serial or model codes
- Item# 740026
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JEB
- 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