Z-0548-2022Class II

INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

Name: Z-0548-2022 INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Creator: Smith & Nephew, Inc.
Published: 2022-01-04
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2022-01-04 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND on 2022-01-04. FDA classified it as Class II and gives the reason as "The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0548-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-04
Posted: 2022-02-01
Recalling firm: Smith & Nephew, Inc.
Product: INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Product code: HRS Plate, Fixation, Bone
Reason for recall: The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by letter and email on 01/04/2022. The letter requested that the consignee examine their inventory, quarantine all affected units, and return the completed response form. Entities who have further distributed the product were directed to notify their customers. The firm is seeking return of the product.
Quantity in commerce: 8 units (US)
Distribution: US Nationwide distribution in the states of CA and OH.
Product codes and lots: UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0548-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0548-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-09	2022-02-01

Product code HRS

K073375Class IINewdeal Tibiaxys SystemNewdeal Sas / cleared 2008-02-21

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)