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Natural-Knee System Patella Bushings. Orthopedic surgical… recallZ-2583-2014 · Zimmer, Inc. · initiated Jul 10, 2014

Class II Terminated All recalls posted in September 2014

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 Zimmer, 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

Zimmer received a trend of complaints indicating corrosion of product.

FDA root cause category: Device Design

What the company is doing

Zimmer issued an Urgent Medical Device Recall-Lot Specific notification via e-mail/letter dated July 19, 2014, to all affected customers. The notification identified the product the problem and the action needed to be taken by the customer. All distributors were notified via electronic mail. Hospital risk managers and surgeons, as well as distributors with affected inventory were notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory as well as identifying hospitals and surgeons who have previously used the affected product. Distributors are to return on-hand affected products to Zimmer, and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative. If you have questions or concerns regarding this recall please call the customer call center at 1-877-946-2761.

Recall details

Recall number
Z-2583-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 10, 2014
Posted by the FDA
Sep 4, 2014
Recalling firm
Zimmer, Inc.
Quantity
8638 distribution events
Product code
JWH
FDA submissions
K073286
Distribution
Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.

Product description

Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Part Number: 6290-00-702. Lots Manufactured by Zimmer: 1324203, 1339203, 1346701, 1363348, 1373979, 1382208, 1385813, 1391253, 1421647, 1437118, 1440906, 1440943, 1451869, 1464915, 1469681, 1470531, 1472373, 1474483, 1538141, 1549267, 1552408, 1554291, 1554292, 1567743, 1598694, 1601263, 1601606, 1606096, 1606957, 170454, 172361, 173342-10, 173342-3, 173342-8, 173342-9, 596146, 597424, 60278535, 60305599, 60319668, 60426581, 60557544, 60712149, 60767845, 60931683, 60946366, 60947929, 60968638, 60970621, 60986924, 60986941, 61025150, 61037537, 61080336, 61080337, 61088939, 61099737, 61099765, 61105152, 61149082, 61240132, 61444750, 61588175, 61799358, 62007189, 62043610, 62123986, 62156012, 62192074, 62216444, 62253081, 62298037, 62304814, 62353344, 625039, 62575710, 640562, 731461, 752886, 783833, 784261, 784530, 789465, 789470, 791153, 791158, 796231, 802256, 803819, 810082, 825360-1, 825360-2, 833061-1, 863221-1, & 869007.  Lots Manufactured by Centerpulse: 10249, 95077, 95316, 95317, 95655, 95656, 96228, 97923, 97923, 97924, 97925, 97926, 97927, 97928, 1141805, 1142824, 1146537, 1146538, 1146673, 1154080, 1155982, 1160641, 1164199, 1164200, 1164232, 1164233, 1179234, 1179235, 1179236, 1179237, 1179238, 1190951, 1190952, 1190953, 1190954, 1190955, 1202697, 1202698, 1202699, 1202700, 1202701, 1202702, 1202703, 1202704, 1202705, 1202706, 1204532, 1238469, 1238470, 1238471, 1238472, 1238473, 1238474, 1238475, 1267914, 1268394, 1268395, 1268396, 1268397, 1299414, 1299415, 1299416, 1306226, 1306227, 1308485, 1308486, 1313079, 1324203, 1332585, 1332695, 1339203, 1340513, 1346701, 1351209, 1353798, 1363348, 1371128, 1373979, 1382208, 1382209, 1385813, 1391253, 1421647, 1437118, 1440906, 1440943, 1451869, 1464915, 1469681, 1470531, 1472373, 1474483, 1538141, 1549267, 1552408, 1554291, 1554292, 1567743, 1583624, 1583727, 1594531, 1594583, 1595925, 1598694, 1601263, 1601606, 1606096, 1606957, 1299414-A, 1299419-A, & 95315-A.

Other devices under the same FDA submission

5 devices cleared under K073286 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 68655).

Sources and updates

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