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Enztec 3.0mm Premium Pin Puller
ENZTEC LIMITED · Model 4000-7300 · UDI-DI 09421028118699
5
510(k) clearances
3,487
Adverse events
4
Recalls
274
Facilities
Description
A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-07 | Innomed, Inc. | 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade. |
| 2018-03-19 | Synthes, Inc. | There is a potential for the connection screw of the stem extractor to break. |
| 2010-11-10 | Encore Medical, Lp | Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay. |
| 2010-03-02 | Stryker Howmedica Osteonics Corp. | Literature did not include the design change to a smaller cannulation diameter. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.