KWRClass IIIImplant

Prosthesis, Shoulder, Constrained, Metal/metal Or Metal/polymer Cemented

Orthopedic · 21 CFR 888.3640

Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96

MDR events170All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances0All time

Recent MDR events

170 adverse event reports on file

Event type breakdown

Injury156

Malfunction10

Other3

Unspecified1

Most-reported manufacturers

Zimmer Inc57 Depuy Orthopaedics, Inc.39 Depuy France S.a.19 Encore Medical, L.p.6 Tornier Inc.6 Zimmer, Inc.6 Unspecified4 3003895575 Depuy France S.a.s.-saint Priest3

Recalls

1 recall events for this product code

The Anspach Effort, Inc.
TerminatedJun 25, 2014
ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only***
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Z-1918-2014 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.