CLASS II Device recall · Reported 16 Jul 2014 · FDA Enforcement Report
Zimmer Edi Periarticular Plating System Cancellous Bone recalled
Zimmer Manufacturing B.V is recalling Zimmer Edi Periarticular Plating System Cancellous Bone Screw, Fully Threaded, Hex Head, distributed nationwide in the US. The recall was initiated on 12 Jun 2014 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-2032-2014
- FDA event ID
- 68547
- Recalling firm
- Zimmer Manufacturing B.V, Mercedita, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2014
- FDA classified
- 10 Jul 2014
- Reported
- 16 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 12 Jun 2014 | Recall initiated by company | |
| 10 Jul 2014 | Classified by FDA | +28 days |
| 16 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.
Where it was distributed
Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.
Questions about this recall
Is Zimmer Edi Periarticular Plating System Cancellous Bone Screw, Fully Threaded, Hex Head recalled?
Yes. Zimmer Manufacturing B.V recalled Zimmer Edi Periarticular Plating System Cancellous Bone Screw, Fully Threaded, Hex Head on 12 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-2032-2014.
Why was it recalled?
Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.
Which lots are affected?
Lot No. 62629432 Lot No. 62628759
Where was it sold?
Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and 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
All 90| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Periarticular plating system, cancellous bone screw recalled | Zimmer Manufacturing B.V | Sterility | Nationwide |
| Device | CLASS II | Mini MagnaFx Cannulated Screw Fixation System Small recalled | Zimmer Manufacturing B.V | Sterility | Nationwide |
| Device | CLASS II | Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled | Zimmer Manufacturing B.V | Sterility | Nationwide |
| Device | CLASS II | Herbert Cannulated Bone Screw System, Bone Screw Dia recalled | Zimmer Manufacturing B.V | Sterility | Nationwide |
| Device | CLASS II | Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled | Zimmer Manufacturing B.V | Sterility | Nationwide |
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