Class II — MEDLINE INDUSTRIES, LP - Northfield
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque. |
| Product | MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008 |
| Quantity | 420 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2022-12-22 |
| Classified | 2023-02-01 |
| Recall number | Z-1045-2023 |
| 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 — MEDLINE INDUSTRIES, LP - Northfield (Z-1045-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91491/
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