Z-0265-2022Class II

Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570...

Name: Z-0265-2022 Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570...
Creator: Smith & Nephew, Inc.
Published: 2021-10-25
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2021-10-25 / Open, Classified / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. began a recall of Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile on 2021-10-25. FDA classified it as Class II and gives the reason as "The labels on the packages of screws were switched". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0265-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-25
Posted: 2021-11-18
Recalling firm: Smith & Nephew, Inc.
Product: Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The labels on the packages of screws were switched.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The recalling firm issued letters dated 10/25/2021 on the same day via email and FedEx overnight. The letter explained the issue and the potential risk of use of the product. Required actions were listed on the enclosed response form. The actions included inspecting their inventory and quarantining the affected product immediately and returning it. Distributors or sales representatives were to notify their customers of the field action and ensure the required actions are complete.
Quantity in commerce: 224 units
Distribution: Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand.
Product codes and lots: REF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0265-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0265-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-18

Product code HRS

K162078Class IIEVOS Small Fragment Plating SystemSmith & Nephew, Inc. / cleared 2016-11-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)