CLASS II Device recall · Reported 25 May 2016 · FDA Enforcement Report
Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled
Zimmer Manufacturing B.V is recalling Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping Length 47483501001 Cortical, distributed nationwide in the US. The recall was initiated on 4 May 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1673-2016
- FDA event ID
- 73981
- Recalling firm
- Zimmer Manufacturing B.V, Mercedita, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 May 2016
- FDA classified
- 16 May 2016
- Reported
- 25 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 4 May 2016 | Recall initiated by company | |
| 16 May 2016 | Classified by FDA | +12 days |
| 25 May 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping Length 47483501001 Cortical recalled?
Yes. Zimmer Manufacturing B.V recalled Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping Length 47483501001 Cortical on 4 May 2016. The recall is Class II and its status is Terminated. Recall number Z-1673-2016.
Why was it recalled?
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Which lots are affected?
LOTS: 63252354 63283819 63308551 63252355 63312340 63252350 63283820 63243831
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zimmer Manufacturing B.V
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|---|---|---|---|---|---|
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| Device | CLASS II | Herbert Cannulated Bone Screw System, Bone Screw Dia recalled | Zimmer Manufacturing B.V | Sterility | Nationwide |
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