Z-1045-2019Class II

JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch...

Name: Z-1045-2019 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch...
Creator: Smith & Nephew, Inc.
Published: 2018-12-10
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2018-12-10 / Terminated / root cause: design

FDA source

Smith & Nephew, Inc. began a recall of JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare... on 2018-12-10. FDA classified it as Class II and gives the reason as "Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1045-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-10
Posted: 2019-03-22
Terminated: 2020-11-03
Recalling firm: Smith & Nephew, Inc.
Product: JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Root cause tag: design
FDA root cause: Device Design
Action: The firm, smith&nephew, initiated the recall by email with an "Urgent Medical Device Recall Notice" letter dated 12/10/18 to the customers on 12/10/2018. Letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -Inspect your inventory and locate any devices from the listed product and batch numbers and quarantine them immediately. - If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. -Complete and return the Response Form to [email protected] or fax to 901-566-7975. Please Note even if you have no product to return, this form must be completed, signed and returned. If you have any questions or concerns regarding this recall please contact [email protected].
Quantity in commerce: 46 units
Distribution: US Distribution to OR and TN; and Internationally to: Japan.
Product codes and lots: Batch Numbers: 17JGA0023; 17JGA0023A; 17JGA0023C; 17JGA0029; 17JGA0029A; 17JGA0029B; 17JGA0035A; 17JGA0035C; 17JGA0045B; 17JGA0045C; 17JGA0045D & 17JGA0045R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1045-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1042-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-22
Z-1043-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-22
Z-1044-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-22
Z-1045-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-22

Product code JWH

K173331Class IIJOURNEY II XR Knee InstrumentsSmith & Nephew, Inc. / cleared 2017-11-16

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)