Z-0730-2019Class II

Sl Plus Mia Double Offset Adapter Right 60/25Mm, S&n 75004613

Name: Z-0730-2019 Sl Plus Mia Double Offset Adapter Right 60/25Mm, S&n 75004613
Creator: Smith & Nephew, Inc.
Published: 2019-01-07
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2019-01-07 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613 on 2019-01-07. FDA classified it as Class II and gives the reason as "The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0730-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-07
Posted: 2019-01-12
Terminated: 2020-09-17
Recalling firm: Smith & Nephew, Inc.
Product: Sl Plus Mia Double Offset Adapter Right 60/25Mm, S&n 75004613
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by email and letter on 01/07/2019. The firm requested the return of the product.
Quantity in commerce: 72 units
Distribution: NY, TN, Germany, Italy, Great Britain, Singapore
Product codes and lots: Lot Numbers: C63165, C63306, C63495

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0730-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0730-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-11

Product code LXH

K123598Class IISmith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. / cleared 2013-06-28

MDM coverage of this record lists here, newest first.

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)