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Precision Allograft Cartilage Kit (PACK™)
Rti Surgical, Inc. · Model PAC-A2532 · UDI-DI 00191083047232
GFG
Prescription
3
510(k) clearances
690
Adverse events
17
Recalls
100
Facilities
Description
PACK Coring Drill, 32mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-03-15 | Smith & Nephew, Inc. | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| 2017-03-15 | Smith & Nephew, Inc. | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| 2017-03-15 | Smith & Nephew, Inc. | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| 2017-03-15 | Smith & Nephew, Inc. | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| 2017-03-15 | Smith & Nephew, Inc. | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| 2017-03-15 | Smith & Nephew, Inc. | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| 2017-03-15 | Smith & Nephew, Inc. | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| 2017-03-15 | Smith & Nephew, Inc. | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| 2017-03-15 | Smith & Nephew, Inc. | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| 2017-03-15 | Smith & Nephew, Inc. | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
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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.