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Synthes GmbH · Model 04.043.520S · UDI-DI 10886982297907
1
510(k) clearances
7,230
Adverse events (11 deaths)
21
Recalls
113
Facilities
Description
TIBIAL NAIL-ADVANCED / 13MM 300MM / STERILE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-26 | Synthes (USA) Products LLC | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46m |
| 2025-09-26 | Synthes (USA) Products LLC | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46m |
| 2022-04-22 | Smith & Nephew Orthopaedics GmbH | Right nails were anodized, marked, and labelled as left nails and vice versa |
| 2020-11-02 | Smith & Nephew, Inc. | Manufacturing packaging error. |
| 2020-06-24 | Smith & Nephew, Inc. | A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve. |
| 2017-10-24 | Smith & Nephew, Inc. | A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down. |
| 2017-02-17 | Zimmer Biomet, Inc. | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. |
| 2015-06-03 | Synthes, Inc. | A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection. |
| 2014-07-02 | Smith & Nephew, Inc. | There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS. |
| 2014-04-04 | Smith & Nephew Inc | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. |
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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.