Device recall: Lateral Troch Plate Full Crimp - 254mm, model # 350837
Class II FDA enforcement event 78167. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Zimmer Biomet, Inc. started this device recall on 5 Jun 2017. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 78167 has 10 product records. The first FDA enforcement report date is 10 Jan 2018. The record gives the status Terminated, with the termination date 6 Mar 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in US; Internationally Argentina, Netherlands & Canada
Recalling firm
Zimmer Biomet, Inc., Warsaw, IN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0296-2018 | Lateral Troch Plate Full Crimp - 254mm, model # 350837 | N/A | Class II | Terminated | 10 Jan 2018 |
| Z-0297-2018 | Lateral Troch Plate Full Crimp - 254mm, model # 350838 | N/A | Class II | Terminated | 10 Jan 2018 |
| Z-0298-2018 | COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 | N/A | Class II | Terminated | 10 Jan 2018 |
| Z-0299-2018 | COMP PRIMARY STEM 8MM MINI, model # 113628 | N/A | Class II | Terminated | 10 Jan 2018 |
| Z-0300-2018 | ECHO POR FMRL NC 9X125, model # 192009 | N/A | Class II | Terminated | 10 Jan 2018 |
| Z-0301-2018 | CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 | N/A | Class II | Terminated | 10 Jan 2018 |
| Z-0302-2018 | CER BIOLOXD OPTION HD 32MM, model # 650-1056 | N/A | Class II | Terminated | 10 Jan 2018 |
| Z-0303-2018 | OSS CEMENTED IM STEM 12X150, model # 150366 | N/A | Class II | Terminated | 10 Jan 2018 |
| Z-0304-2018 | RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817 | N/A | Class II | Terminated | 10 Jan 2018 |
| Z-0305-2018 | RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828 | N/A | Class II | Terminated | 10 Jan 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 10Median of the firm: 1
- Events of the firm on the register
- 144
Other events of the firm
Official channels
- FDA enforcement report Z-0296-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 78167. https://recallregister.com/fda/ii/78167/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in US; Internationally Argentina, Netherlands & Canada
- What quantity of product is in FDA event 78167?
- The event has 10 product records. The first record gives this quantity:
N/A
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.