CLASS II Device recall · Reported 2 Sep 2020 · FDA Enforcement Report
Altera Spacer Altera Spacer, 10-, 8¿ recalled by Globus Medical
Globus Medical is recalling Altera Spacer Altera Spacer, 10-, 8¿. The recall was initiated on 22 Jul 2020 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-2853-2020
- FDA event ID
- 86164
- Recalling firm
- Globus Medical, Audubon, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jul 2020
- FDA classified
- 22 Aug 2020
- Reported
- 2 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 22 Jul 2020 | Recall initiated by company | |
| 22 Aug 2020 | Classified by FDA | +31 days |
| 2 Sep 2020 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿
Where it was distributed
Worldwide Distribution
Questions about this recall
Is Altera Spacer Altera Spacer, 10-, 8¿ recalled?
Yes. Globus Medical recalled Altera Spacer Altera Spacer, 10-, 8¿ on 22 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-2853-2020.
Why was it recalled?
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Which lots are affected?
Part #: 1124.1013; Lot # / UDI #: BAX104GE / (01)00889095069495(10)BAX104GE; BAX156GE / (01)00889095069495(10)BAX156GE; BAX156HE / (01)00889095069495(10)BAX156HE; BAX195WE / (01)00889095069495(10)BAX195WE; BAX361LE / (01)00889095069495(10)BAX361LE
Where was it sold?
Worldwide Distribution
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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