510(k) K102080 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
DEPUY RECLAIM REVISION HIP SYSTEM
| Applicant | Depuy(Ireland), Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 23, 2010 |
| Received | Jul 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102080
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2014 | DePuy Orthopaedics, Inc. RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation Terminated |
KWA | None listed |
| Jul 21, 2014 | DePuy Orthopaedics, Inc. RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the D Terminated |
KWA | None listed |
| Jul 21, 2014 | DePuy Orthopaedics, Inc. RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal St Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.