FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: fastener, fixation, nondegradable, soft tissue
- Recall number
- Z-1009-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- fastener, fixation, nondegradable, soft tissue
- Status
- Terminated
- Initiated
- 2017-10-25
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
- Root cause
- Process control
- Action
- In October of 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers requesting that any remaining product be quarantined and returned to recalling firm. Questions or concerns can be directed to 574-371-3071.
- Quantity
- 429 units
- Distribution
- TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT
- Lot, serial or model codes
- Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370
- 510(k) numbers
- ["K143037"]
- PMA numbers
- not on file
- Product code
- MBI
- 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