Z-0776-2020Class II

Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST

Name: Z-0776-2020 Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
Creator: Nextremity Solutions
Published: 2019-11-11
License: https://open.fda.gov/license/

Medartis AG / initiated 2019-11-11 / Terminated / root cause: packaging

FDA source

Nextremity Solutions began a recall of Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST on 2019-11-11. FDA classified it as Class II and gives the reason as "Components 2mm shorter than indicated on the package label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0776-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-11
Posted: 2020-01-03
Terminated: 2020-09-10
Recalling firm: Medartis AG
Product: Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
Product code: HWC Screw, Fixation, Bone
Reason for recall: Components 2mm shorter than indicated on the package label
Root cause tag: packaging
FDA 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 in commerce: 87 units
Distribution: Nationwide
Product codes and lots: Lot Number: M1266 UDI: 00817701023159

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0776-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0776-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-03
Z-0777-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-03
Z-0778-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-03

Product code HWC

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

China's FDA-registered implant bench is 151 establishments of 4,70415 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)