Musculoskeletal Transplant Foundation — Class II medical device recall Z-2004-2016
Terminated recall by Musculoskeletal Transplant Foundation, Inc., reported 2016-07-13, distributed nationwide. AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyv
| Recall number | Z-2004-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Musculoskeletal Transplant Foundation, Inc., Edison, NJ, United States |
| Recall initiated | 2016-04-21 |
| Classified | 2016-07-07 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2016-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 114 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04314046801122 |
| Serial numbers | 04314046801122 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2004-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.