Class II — Musculoskeletal Transplant Foundation, Inc.
| Recalling firm | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field. |
| Product | Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005. |
| Quantity | 114 units |
| Distribution | nationwide |
| Initiated | 2016-04-21 |
| Classified | 2016-07-07 |
| Terminated | 2016-10-18 |
| Recall number | Z-2004-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Musculoskeletal Transplant Foundation, Inc. (Z-2004-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74263/
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