FDAClass IIJanuary 20, 2016

Zimmer Universal Locking System 3.5mm Locking recall

Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual…

Why was Zimmer Universal Locking System 3.5mm Locking recalled?

The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part 00-4936-011-13, Lot 62968956 3.5MM ULS RECON PLATE 11H Part 00-4936-008-07, Lot 62968974 3.5MM ULS DUAL COMP PLT 8

Product
Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual…
Recalling firm
Zimmer Biomet, Inc.
Quantity
52
Distribution
Worldwide Distribution -- USA, including the states of MN, NY, MS, AL, OH, KY, ME, and NM; and, the countries of Taiwan, Korea, Singapore, El Salvador, Uruguay, Czech Republic, France, Italy, Poland, United Kingdom, South Africa, and Slovakia.
Recall date
January 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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