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Compress Device recallZ-0553-2019 · Zimmer Biomet, Inc. · initiated Oct 24, 2018

Terminated

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

Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted

FDA root cause category: Employee error

What the company is doing

Zimmer Biomet initiated recall by letter on 10/24/18 to distributors and hospitals advising of the problem and action to be taken-locate quarantine and return product. Complete Inventory Return Certification Form. Questions or concerns call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

Recall details

Recall number
Z-0553-2019
Status
Terminated
Initiated by the company
Oct 24, 2018
Recalling firm
Zimmer Biomet, Inc.
Quantity
6 units
Product code
JDI
FDA submissions
K062998
Distribution
US Nationwide Distribution in the states of IN, DC, MD

Product description

Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma. The Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) components are intended for uncemented use only.

Code information (models, lots, serial numbers)

Lot Number: 608740 UDI Number: (01)00880304461666(17)271113(10)608740

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

14 devices cleared under K062998 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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