Z-2163-2018Class II

smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

Name: Z-2163-2018 smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Creator: Smith & Nephew, Inc.
Published: 2018-05-04
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2018-05-04 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. began a recall of smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1) on 2018-05-04. FDA classified it as Class II and gives the reason as "One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification". 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-2163-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-04
Posted: 2018-06-11
Terminated: 2019-02-22
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm initiated the recall by email on 05/04/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return.
Quantity in commerce: 5 units
Distribution: International only: United Arab Emirates, Spain, Mexico
Product codes and lots: 15FM16181

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2163-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2163-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-11

Product code MBH

K121393Class IISmith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. / cleared 2012-08-07

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)