Tray Set containing multiple instruments and may contain the flexible… — Class II medical device recall Z-0448-2016
Terminated recall by Aesculap, Inc., reported 2015-12-30, distributed nationwide. The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay i
| Recall number | Z-0448-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2015-11-10 |
| Classified | 2015-12-18 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-09-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | device malfunction |
Product
Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037.
Reason for recall
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
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-0448-2016. 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.