Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in units 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 (surgical instrument fracture) where the source text does not explicitly report patient injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
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 with 455 stainless steel, as all reported fractured instruments were made with this material. The recall is classified as Class II by the FDA.
The affected products are part of a worldwide distribution, including nationwide distribution in the United States and international distribution to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom. The specific part number is 00-4309-028-00, and the recall covers 185 units, with 162 located in the USA. Specific lot numbers affected include 60443178, 60545332, 60549563, 60605851, 60612791, 60720047, 60758647, 60773944, 60836577, 60896973, 60973522, 61019783, and 61024158.
Healthcare providers and facilities should check their inventory for these specific part and lot numbers. If the recalled instruments are found, they should be removed from service and returned to Zimmer, Inc. according to the company's instructions. Consumers who have had these instruments used in their surgery should contact their healthcare provider for guidance.
The recalled product
- 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, plac
- 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 (10)
- part 00-4309-028-00
- lot 60443178
- 60545332
- 60549563
- 60605851
- 60612791
- 60720047 60758647 60773944 60836577 60896973
- 60973522
- 61019783
- 61024158
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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