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PYRAMESH® Implant System
MEDTRONIC SOFAMOR DANEK, INC. · Model 905-312 · UDI-DI 00763000855482
2
510(k) clearances
2,930
Adverse events (14 deaths)
46
Recalls
223
Facilities
Description
MESH 905-312 PYRM 13MM X 12MM ROUND
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-10 | NuVasive Inc | Potential that insert will be unable to disengage from the vertebral body replacement device/implant |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.