Z-1028-2019Class II

smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510

Name: Z-1028-2019 smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Creator: Smith & Nephew, Inc.
Published: 2019-02-19
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2019-02-19 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. began a recall of smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510 on 2019-02-19. FDA classified it as Class II and gives the reason as "Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"". 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-1028-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-19
Posted: 2019-03-20
Terminated: 2021-05-21
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm notified its direct accounts by email and letter on 02/18/2019. The notice requested return of the recalled products. Distributors were directed to notify their customers of the recall and ensure that the actions are carried out.
Quantity in commerce: 58 units
Distribution: US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain
Product codes and lots: Batch Numbers: 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035 & 18CM08027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1028-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1028-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-20
Z-1029-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-20

Product code LPH

K103256Class IISmith & Nephew Smf Hip StemSmith & Nephew, Inc. / cleared 2011-01-31

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)