Device recall: Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
Class II FDA enforcement event 72366. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
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
Biomet Microfixation, LLC started this device recall on 6 Aug 2015. The firm address in the FDA record is in Jacksonville, FL. FDA put the recall in Class II. FDA event 72366 has 2 product records. The first FDA enforcement report date is 28 Oct 2015. The record gives the status Terminated, with the termination date 13 Oct 2017.
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 Distribution including CA, FL, OK, NY, NC, and IL.
Recalling firm
Biomet Microfixation, LLC, Jacksonville, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0136-2016 | Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage. | 37 cases | Class II | Terminated | 28 Oct 2015 |
| Z-0137-2016 | Thinflap System Case The cases hold surgical instrumentation in place during handling and storage. | 5 units | Class II | Terminated | 28 Oct 2015 |
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 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Apr 2017 | Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 | Device | Class II | 1 |
| 13 Jun 2016 | Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are | Device | Class II | 1 |
| 17 Oct 2014 | Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand | Device | Class II | 14 |
| 20 Sep 2013 | Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0136-2016The 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 72366. https://recallregister.com/fda/ii/72366/. 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 Distribution including CA, FL, OK, NY, NC, and IL.
- What quantity of product is in FDA event 72366?
- The event has 2 product records. The first record gives this quantity:
37 cases
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.