Device recall: ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Class II FDA enforcement event 86164. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
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
Globus Medical, Inc. started this device recall on 22 Jul 2020. The firm address in the FDA record is in Audubon, PA. FDA put the recall in Class II. FDA event 86164 has 22 product records. The first FDA enforcement report date is 2 Sep 2020. The record gives the status Terminated, with the termination date 19 Aug 2021.
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.
Worldwide Distribution
Recalling firm
Globus Medical, Inc., Audubon, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
22 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2850-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile) | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2851-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2852-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2853-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2854-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2855-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2856-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2857-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2858-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2859-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2860-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2861-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2862-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2863-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2864-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2865-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2866-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2867-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2868-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2869-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2870-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿ | N/A | Class II | Terminated | 2 Sep 2020 |
| Z-2871-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿ | N/A | Class II | Terminated | 2 Sep 2020 |
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 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 22Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Apr 2025 | MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; | Device | Class II | 1 |
| 15 Dec 2023 | ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 | Device | Class II | 1 |
| 11 Dec 2023 | Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices w | Device | Class II | 3 |
| 7 Dec 2023 | ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 | Device | Class I | 1 |
| 28 Aug 2013 | Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voi | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2850-2020The 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 86164. https://recallregister.com/fda/ii/86164/. 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:
Worldwide Distribution
- What quantity of product is in FDA event 86164?
- The event has 22 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 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.