Z-0534-2020Class II

Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST -

Name: Z-0534-2020 Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST -
Creator: Nextremity Solutions
Published: 2019-10-09
License: https://open.fda.gov/license/

Medartis AG / initiated 2019-10-09 / Terminated / root cause: labeling and UDI

FDA source

Nextremity Solutions began a recall of 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... on 2019-10-09. FDA classified it as Class II and gives the reason as "Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0534-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-09
Posted: 2019-11-22
Terminated: 2020-06-24
Recalling firm: Medartis AG
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.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
Root cause tag: labeling and UDI
FDA 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 in commerce: 49 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Number: M1151 UDI: 00817701022558

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0534-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0534-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22

Product code HRS

K182201Class IIStratum™ Foot Plating SystemNextremity Solutions, Inc. / cleared 2018-11-16

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)