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Carbon fibre back plate

MAQUET GmbH · Model 118037F0 · UDI-DI 04046768040892

BWN
10
510(k) clearances
223
Adverse events (1 deaths)
74
Recalls
152
Facilities

Recalls

DateFirmReason
2021-09-13Innovative Orthopedic Technologies, LLCDue to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.

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Data 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.