FDA Medical Device Recalls (openFDA)
Nextremity Solutions: Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.
- Recall number
- Z-0534-2020
- Recalling firm
- Nextremity Solutions
- Product
- Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.
- Status
- Terminated
- Initiated
- 2019-10-09
- Posted
- not on file
- Terminated
- 2020-06-24
- Reason
- Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
- Root cause
- Labeling mix-ups
- Action
- Nextremity Solutions issued Urgent Medical Device notification dated 10/09/19, identifying product, reason for recall, health risk and action to take: review inventory , quarantine for product for return and contact your Zimmer Biomet Rep. will remove product from your facility. Complete and return the Medical Device Response Form. Questions contact customer service 574-371-3071, 8 am-5pm, M-F (EST).
- Quantity
- 49 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Number: M1151 UDI: 00817701022558
- 510(k) numbers
- ["K182201"]
- PMA numbers
- not on file
- Product code
- HRS
- 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