CLASS II Device recall · Reported 2 Sep 2020 · FDA Enforcement Report

Altera Spacer Altera Spacer, 8-, 8¿ (sterile) recalled

Globus Medical is recalling Altera Spacer Altera Spacer, 8-, 8¿ (sterile). The recall was initiated on 22 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart #: 1124.1111S; Lot#/UDI #: GBX132UC / (01)00889095720723(17)250511(10)GBX132UC

Quantity recalledN/A

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-2850-2020
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, 10x31, 8-12mm, 8¿ (sterile)

Where it was distributed

Worldwide Distribution

Questions about this recall

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 #: 1124.1111S; Lot#/UDI #: GBX132UC / (01)00889095720723(17)250511(10)GBX132UC

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

21 other products · FDA event 86164

This product is part of a recall event; the main page for the event is Altera Spacer Altera Spacer, 10-, 15¿ recalled by Globus Medical.

Reported	Class	Recall	Company	Reason	Where
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 10-, 15¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 12-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 12-, 15¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 8-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 12-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 9-, 15¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 10-, 15¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 9-, 15¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 12-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 8-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 9-, 15¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 9-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 9-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 10-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 10-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 9-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 10-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 10-, 15¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 12-, 15¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 8-, 8¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA
2 Sep 2020	CLASS II	Altera Spacer Altera Spacer, 12-, 15¿ recalled by Globus Medical	Globus Medical	Foreign Material	PA

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