Extremity Medical — Class II medical device recall Z-0952-2013
Terminated recall by Extremity Medical LLC, reported 2013-03-27, distributed in AZ, CA, FL, IL, MD, NC, NH, NY…. The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement readi
| Recall number | Z-0952-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Extremity Medical LLC, Parsippany, NJ, United States |
| Recall initiated | 2013-01-10 |
| Classified | 2013-03-15 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2013-07-18 |
| Distributed | AZ, CA, FL, IL, MD, NC, NH, NY, OH, OK, PA, TN, TX, VA |
| Countries outside the US | AU, BE, GB, IL, NL |
| Quantity | 238 units |
| Lot numbers | 00921538 |
| Model numbers | 101-00006 |
Product
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.
Reason for recall
The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
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-0952-2013. 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.