Z-1127-2020Class II

Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the...

Name: Z-1127-2020 Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the...
Creator: Nextremity Solutions
Published: 2019-12-16
License: https://open.fda.gov/license/

Medartis AG / initiated 2019-12-16 / Terminated / root cause: labeling and UDI

FDA source

Nextremity Solutions began a recall of Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws... on 2019-12-16. FDA classified it as Class II and gives the reason as "The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate". 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-1127-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-16
Posted: 2020-02-11
Terminated: 2020-09-08
Recalling firm: Medartis AG
Product: Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On December 16, 2019, the firm notified customers and distributors via recall notification letter and e-mail. The notification instructed return of all product with the specified lot number. If customers have any questions, please call customer service at 574-371-3071 between 8AM-5PM EST, Monday thru Friday. Alternatively, questions may be emailed to [email protected].
Quantity in commerce: 40
Distribution: Domestic distribution to AL, CA, FL, GA, ID, IL, IA, KY, LA, ME, MA, MI, MN, MS, NE, NJ, NY, OH ,OK, OR, TX, and WA.
Product codes and lots: Lot M1502

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1127-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1127-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-10

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)