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Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE… recallZ-2032-2014 · Zimmer Manufacturing B.V. · initiated Jun 12, 2014

Class II Terminated All recalls posted in July 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 Manufacturing B.V. 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

Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.

FDA root cause category: Process design

What the company is doing

Zimmer sent an Urgent Medical Device Recall Lot specific letter dated June 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. Please locate, quarantine, and return the affected product (part number 00-4840-020-00 lot number 62629432 and part number 00-2347-022-14 lot number 62628759) from all inventories. 2. Please note that any hospitals that received direct shipments of this product from Zimmer will be notified via Fed Ex. 3. Please review the list of hospital and surgeons to be provided to your territory via email. 4. Provide the name, address, and phone number of any additional hospitals or surgeons that may have received or used the affected product, or confirm that the list provided is complete. 5. Complete and return Attachment 1. 6. Ensure that a copy of the Risk Managers and Surgeons letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer. 7. If after reviewing this notification you have questions or concerns, please contact Zimmer at 1-877-946-2761.

Recall details

Recall number
Z-2032-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 12, 2014
Posted by the FDA
Jul 10, 2014
Recalling firm
Zimmer Manufacturing B.V.
Quantity
496
Product code
HWC
FDA submissions
K934765
Distribution
Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.

Product description

Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.

Code information (models, lots, serial numbers)

Lot No. 62629432 Lot No. 62628759

Other devices under the same FDA submission

8 devices cleared under K934765 — 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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