Use caution Medical device recall · FDA · Published December 10, 2018

Smith & Nephew Journey II XR Tibial Posterior Keel Punch Recall: Bone Fracture Risk

Smith & Nephew recalls certain Journey II XR Tibial Posterior Keel Punches due to higher than expected bone fracture risk during use. Affected units have specific batch numbers. Consumers should contact the company for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1043-2019Medical device Smith & Nephew ›

Use caution until it’s fixed

Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch

Take action

Contact the company

Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804

✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling certain Journey II XR Tibial Posterior Keel Punches because they can cause bone fractures during use. This recall affects specific batch numbers of the surgical instrument used in orthopedic procedures. Read more at govinfonow.com/recall/69358-smith-nephew-journey-ii-xr-tibial-posterior-keel-punch-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/69358-smith-nephew-journey-ii-xr-tibial-posterior-keel-punch-recall · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1043-2019

Cite this page

“Smith & Nephew Journey II XR Tibial Posterior Keel Punch Recall: Bone Fracture Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69358-smith-nephew-journey-ii-xr-tibial-posterior-keel-punch-recall. Based on FDA recall #Z-1043-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1043-2019%22&limit=1).

Smith & Nephew, Inc. recalled the JOURNEY II XR Tibial Posterior Keel Punch on Dec. 10, 2018, after the FDA announced a Class II recall due to the hazard of bone fracture during use. The Food and Drug Administration issued the recall under agency number Z-1043-2019.

How to tell if you have it

Brand: Smith & Nephew
Product: JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4, REF 74013987
Batch Numbers: 17JGA0021; 17JGA0021A; 17JGA0027; 17JGA0027A; 17JGA0027B; 17JGA0033A; 17JGA0033B; 17JGA0043; 17JGA0043A; 17JGA0043B; 17JGA0043R; 17JGA0047 & 18BGA0014B
Distribution: US (OR, TN) and Japan
Units affected: 65

The hazard

The recall cites a higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch. The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibia to receive a JOURNEY II XR tibial baseplate.

Context

GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls on record since July 24, 2017. Other recent recalls of similar products include the Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), the Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), and the Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025). Other recent recalls of similar products include the Orthalign Drill Plate Recall (Feb. 10, 2026) and the Biomet Intramedullary Bone Saw Blade Recall (July 1, 2026).

How to tell if you have this one

Check the batch numbers on the instrument: 17JGA0021, 17JGA0021A, 17JGA0027, 17JGA0027A, 17JGA0027B, 17JGA0033A, 17JGA0033B, 17JGA0043, 17JGA0043A, 17JGA0043B, 17JGA0043R, 17JGA0047, and 18BGA0014B.

Brand
Smith & Nephew
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Distribution to OR and TN; and Internationally to: Japan.

Recall number	Product, codes & lots	Quantity
Z-1042-2019	JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 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.; Batch Numbers: 17JGA0020; 17JGA0020A; 17JGA0020B; 17JGA0026; 17JGA0026A; 17JGA0026B; 17JGA0032A; 17JGA0032B; 17JGA0042; 17JGA0042A; 17JGA0042R	65 units
Z-1043-2019	JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 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.; Batch Numbers: 17JGA0021; 17JGA0021A; 17JGA0027; 17JGA0027A; 17JGA0027B; 17JGA0033A; 17JGA0033B; 17JGA0043; 17JGA0043A; 17JGA0043B; 17JGA0043R; 17JGA0047 & 18BGA0014B	65 units
Z-1044-2019	JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , 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.; Batch Numbers: 17JGA0022; 17JGA0022A; 17JGA0022B; 17JGA0028; 17JGA0028A; 17JGA0028B; 17JGA0034A; 17JGA0034C; 17JGA0044; 17JGA0044B; 17JGA0044R; 18BGA0015A & 18BGA0015B	65 units
Z-1045-2019	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.; Batch Numbers: 17JGA0023; 17JGA0023A; 17JGA0023C; 17JGA0029; 17JGA0029A; 17JGA0029B; 17JGA0035A; 17JGA0035C; 17JGA0045B; 17JGA0045C; 17JGA0045D & 17JGA0045R	46 units

Based on the official FDA remedy

What to do — step by step

Check Batch Numbers
Look for batch numbers on the instrument: 17JGA0021, 17JGA0021A, 17JGA0027, 17JGA0027A, 17JGA0027B, 17JGA0033A, 17JGA0033B, 17JGA0043, 17JGA0043A, 17JGA0043B, 17JGA0043R, 17JGA0047, and 18BGA0014B.

Where it went and when

Where it was distributed

Distributed in Oregon and Tennessee, and outside the U.S.

FDA distribution: “US Distribution to OR and TN; and Internationally to: Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Oregon, Tennessee.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Dec 10, 2018Firm started the recall
Mar 22, 2019FDA classified it Class II
Apr 3, 2019Published in FDA’s Enforcement Report
Nov 3, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69358-smith-nephew-journey-ii-xr-tibial-posterior-keel-punch-recall">Smith &amp; Nephew Journey II XR Tibial Posterior Keel Punch Recall: Bone Fracture Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1043-2019 (December 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1043-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.