Z-2625-2017Class II

LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM...

Name: Z-2625-2017 LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM...
Creator: Smith & Nephew, Inc.
Published: 2017-05-30
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-05-30 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM on 2017-05-30. FDA classified it as Class II and gives the reason as "The incorrect Loctite adhesive was used to assemble the impactor heads". 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-2625-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-30
Posted: 2017-06-12
Terminated: 2021-12-10
Recalling firm: Smith & Nephew, Inc.
Product: LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The incorrect Loctite adhesive was used to assemble the impactor heads.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified the consignee by email on 05/30/2017. The notice directed the consignee to inspect its inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. Distributors were directed to notify their customers of the field action and ensure the recall directions were followed.
Quantity in commerce: 46 units
Distribution: US distribution to TN
Product codes and lots: Lot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2625-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2624-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-23
Z-2625-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-23

Product code JWH

K162775Class IILegion Cone SystemSmith & Nephew, Inc. / cleared 2017-01-13

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)