Zimmer, Inc. Recall: 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ N
Zimmer, Inc. Recall: 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ N is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Zimmer, Inc.; Product: 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle Per surgical technique 97-4309-003-00 Revisio
| Recalling firm | Zimmer, Inc. |
|---|---|
| Product | 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle 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." |
| Reason for recall | 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom. |
| Recall initiated | 20120718 |
| Recall number | Z-2215-2012 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
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