Z-1921-2018Class II

smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip...

Name: Z-1921-2018 smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip...
Creator: Smith & Nephew, Inc.
Published: 2018-05-02
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2018-05-02 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis on 2018-05-02. FDA classified it as Class II and gives the reason as "Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm". 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-1921-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-02
Posted: 2018-05-09
Terminated: 2020-09-01
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by letter on 05/02/2018. 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. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out. For further questions, please call (978) 749-1440
Quantity in commerce: 13 units
Distribution: US nationwide distribution.
Product codes and lots: Lot Numbers: 17LM22019, 17LM10934, 17LM05900

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1921-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1921-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-23

Product code JDI

K052792Class IIAnthology Hip StemSmith & Nephew, Inc. / cleared 2005-10-07

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)