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Zimmer Plates and Screws (ZPS) recallZ-1673-2016 · Zimmer Manufacturing B.V. · initiated May 4, 2016

Class II Terminated All recalls posted in May 2016

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

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

FDA root cause category: Packaging change control

What the company is doing

All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.

Recall details

Recall number
Z-1673-2016
Recall class
Class II
Status
Terminated
Initiated by the company
May 4, 2016
Posted by the FDA
May 16, 2016
Recalling firm
Zimmer Manufacturing B.V.
Quantity
794
Product code
HWC
FDA submissions
K060710
Distribution
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.

Product description

Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401 3.5 mm Cortical Screw SelfTapping, 30 mm Length 47483503001 3.5 mm Cortical Screw SelfTapping, 40 mm Length 47483504001 3.5 mm Cortical Screw SelfTapping, 75 mm Length 47483507501

Code information (models, lots, serial numbers)

LOTS: 63252354 63283819 63308551 63252355 63312340 63252350 63283820 63243831

Other devices under the same FDA submission

13 devices cleared under K060710 — 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 73981).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page