Device product
Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet."
Z-2212-2012
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 62540
- Status
- Terminated
- Classification
- Class II
- Quantity
- 185 (162 in USA)
- Official record key
device-enforcement:Z-2212-2012
Official wording
Reason: Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stain
Code information: part 00-4309-028-00, lot 60443178, 60545332, 60549563, 60605851, 60612791, 60720047 60758647 60773944 60836577 60896973, 60973522, 61019783, 61024158
Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.
Derived failure modes
-
Unknown
Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stain