ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Reported: September 2, 2020 Initiated: July 22, 2020 #Z-2850-2020
Product Description
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
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.
Details
- Recalling Firm
- Globus Medical, Inc.
- Units Affected
- N/A
- Distribution
- Worldwide Distribution
- Location
- Audubon, PA
Frequently Asked Questions
What product was recalled? ▼
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile). Recalled by Globus Medical, Inc.. Units affected: N/A.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2020. Severity: Moderate. Recall number: Z-2850-2020.
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