FDA Medical Device Recalls (openFDA)
Nextremity Solutions: Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
- Recall number
- Z-0777-2020
- Recalling firm
- Nextremity Solutions
- Product
- Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
- Status
- Terminated
- Initiated
- 2019-11-11
- Posted
- not on file
- Terminated
- 2020-09-10
- Reason
- Components 2mm shorter than indicated on the package label
- Root cause
- Packaging process control
- Action
- Nextremity Solutions issued Urgent Medical Device Recall letter on 11/11/19 stating reason for recall, health risk and action to take: do not use, quarantine and return to Zimmer Biomet representative who will remove product, Contact customer service at 574-371-3071 between 8am -5pm(EST) M-F.
- Quantity
- 86 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number: M1267 UDI: 00817701023166
- 510(k) numbers
- ["K182201"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3009540749
- 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