—#169783

Product

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.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K173331
Affected lot / code info: Batch Numbers: 17JGA0022; 17JGA0022A; 17JGA0022B; 17JGA0028; 17JGA0028A; 17JGA0028B; 17JGA0034A; 17JGA0034C; 17JGA0044; 17JGA0044B; 17JGA0044R; 18BGA0015A & 18BGA0015B

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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 FieldActions@smith-nephew.com 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 FieldActions@smith-nephew.com.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: US Distribution to OR and TN; and Internationally to: Japan.

Timeline

Recall initiated: 2018-12-10
Terminated: 2020-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169783. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.