CLASS II Device recall · Reported 4 Oct 2017 · FDA Enforcement Report
Zimmer Periarticular Locking Plate System Drill Standard Diameter recalled
Zimmer Biomet is recalling Zimmer Periarticular Locking Plate System Drill Standard Diameter, distributed nationwide in the US. The recall was initiated on 22 May 2017 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-3180-2017
- FDA event ID
- 77417
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 May 2017
- FDA classified
- 22 Sep 2017
- Reported
- 4 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 22 May 2017 | Recall initiated by company | |
| 22 Sep 2017 | Classified by FDA | +123 days |
| 4 Oct 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
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 Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile. orthopedic surgical instrument.
Where it was distributed
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
Questions about this recall
Is Zimmer Periarticular Locking Plate System Drill Standard Diameter recalled?
Yes. Zimmer Biomet recalled Zimmer Periarticular Locking Plate System Drill Standard Diameter on 22 May 2017. The recall is Class II and its status is Terminated. Recall number Z-3180-2017.
Why was it recalled?
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Which lots are affected?
Lot Numbers: 63599481, 63461425, 63469758, 63469758, 63475225 & 63481881.
Where was it sold?
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
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.
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| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |