Cortical Screw for M/DN Intramedullary Fixation — Class II medical device recall Z-1694-2015
Terminated recall by Zimmer, Inc., reported 2015-06-10, distributed nationwide. The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the
| Recall number | Z-1694-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-04-29 |
| Classified | 2015-05-29 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2015-12-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, BR, BS, CA, CH, CN, DE, DZ, ES, FR, GB, IN, IQ, IT, JO, JP, KR, LB, LT, MA, MT, MX, MY, NI, RS, SA, SG, TH, TW |
| Quantity | 289,616 |
| Reason classes | device malfunction |
| Model numbers | 00-2253-020-45 |
Product
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
Reason for recall
The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to lead to a situation in which the screw would bind upon entering the nail and have to be removed during the surgery or removal of the screw after fracture healing.
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-1694-2015. 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.