Zimmer Trabecular Metal Reverse Shoulder Liner Impactors Recalled for Fractures
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in instruments made of 455 stainless steel.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (instrument fracture) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Zimmer, Inc. is recalling Trabecular Metal (TM) Reverse Shoulder Liner Impactors because of reports of alignment peg fractures. The recall specifically targets all lots of these instruments manufactured from 455 stainless steel, as all reported fractured instruments were made with this material. The recall does not apply to units manufactured with 13-8 stainless steel.
The affected product is the 00-4309-028-01 Trabecular Metal Reverse Shoulder Liner 40mm 65° Neck Angle. A total of 252 units were distributed, with 210 units in the United States and the remainder distributed internationally to Germany, Belgium, Denmark, Finland, France, Italy, the Netherlands, Spain, Sweden, Switzerland, and the United Kingdom. Specific lot numbers affected include 60529860, 60574377, 60589079, 60605856, 60616574, 60684774, 60842967, 60739623, 60896979, 60936815, 61019785, and 61051017.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected instruments. Patients who have had these instruments used during surgery should contact their healthcare provider for guidance.
The recalled product
- Product
- 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 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
- Manufacturer
- Zimmer, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Part 00-4309-028-01: Lot 60529860
- 60574377
- 60589079
- 60605856
- 60616574
- 60684774
- 60842967
- 60739623
- 60896979
- 60936815
- 61019785
- 61051017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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