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Zimmer Trabecular Metal Reverse Shoulder System… recallZ-3144-2017 · Zimmer Biomet, Inc. · initiated May 22, 2017

Class II Terminated All recalls posted in September 2017

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 Biomet, 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

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

FDA root cause category: Process control

What the company is doing

On 5/22/2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers and distributors. On 12/19/2017, Zimmer Biomet sent Urgent Medical Device Recall notices to their customers due to a recall expansion involving one (1) lot for product # 20. Customers are advised to review the notice and ensure that affected personnel are aware of the contents. All stock should be inspected and product quarantined. A Zimmer Biomet sales representative will remove the affected product from your facility. Customers should complete and return the Certificate of Acknowledgement via email to: [email protected] and retain the copy for your files. Customers with questions may call the customer call center at 574-371-3071, Monday through Friday 8 am - 5 pm, EST. *For Distributors Your Responsibilities include the following: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet. a. For each return, send a copy of the completed acknowledgement form via email to: [email protected]. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Include a copy of Attachment 3 Certificate of Sterilization with returned instruments. d. Mark the outside of the returns box(es) clearly with FIELD ACTION. 5. Note that any hospitals that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager Field Action Notice direc

Recall details

Recall number
Z-3144-2017
Recall class
Class II
Status
Terminated
Initiated by the company
May 22, 2017
Posted by the FDA
Sep 22, 2017
Recalling firm
Zimmer Biomet, Inc.
Quantity
2825 units
Product code
KWT
FDA submissions
K052906
Distribution
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

Product description

Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile

Code information (models, lots, serial numbers)

Lot Numbers: 63399406, 63399407, 63413258, 63418122, 63419454, 63421749, 63471169, 63471170, 63471171, 63474753, 63474754, 63484232, 63501370, 63633540, 63649266 & 63655091.

Other devices under the same FDA submission

34 devices cleared under K052906 — 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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