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Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR… recallZ-0573-2016 · Smith & Nephew, Inc. · initiated Nov 9, 2015

Class II Terminated All recalls posted in January 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.

FDA root cause category: Process design

What the company is doing

The firm, Smith & Nephew Inc, notified the distributors by Fed- Ex on 10/20/2015 and sent an "Urgent - Product Recall 1st Notification - Urgent R-2015-22" letter dated 11/9/2015 to their customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect your inventory and locate any unused devices, quarantine them immediately, complete and return the Inventory Return Certification Form by fax to: +1-901-566-7975 or email to: [email protected], even if you do not have the product, contact Smith & Nephew's Field Actions Department via email or fax (above) to obtain a return authorization (RA) number, and return any affected product to Smith & Nephew, Attn: Global Field Actions, Global Distribution Center, 3303 E Holmes Road, Memphis, TN 38118. If you have any questions, call Director, Regulatory Affairs 901-399-5520 or email: [email protected].

Recall details

Recall number
Z-0573-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 9, 2015
Posted by the FDA
Jan 4, 2016
Recalling firm
Smith & Nephew, Inc.
Quantity
20 units
Product code
JWH
FDA submissions
K951987
Distribution
US Distribution to states of:FL, MO, IN and TX.

Product description

Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.

Code information (models, lots, serial numbers)

Batch # 15GM07831

Other devices under the same FDA submission

137 devices cleared under K951987 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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