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OsteoMed
OSTEOMED LLC · Model 213-1607 · UDI-DI 00845694033763
DZL
Prescription
10
510(k) clearances
1,522
Adverse events
8
Recalls
73
Facilities
Description
Low Profile 2 x 2 Hole Large Plate
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-02-23 | Synthes (USA) Products LLC | Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the th |
| 2016-02-23 | Synthes (USA) Products LLC | Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the th |
| 2013-05-31 | Synthes USA HQ, Inc. | Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm r |
| 2013-01-11 | Synthes USA HQ, Inc. | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. |
| 2013-01-11 | Synthes USA HQ, Inc. | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. |
| 2013-01-11 | Synthes USA HQ, Inc. | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. |
| 2010-03-17 | Biomet Microfixation, Inc. | Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws. |
| 2009-10-06 | Biomet 3i, LLC | Biomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufactured with a materi |
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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.