Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors
Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the hazard involves instrument failure (alignment peg fractures) which poses a risk of harm during surgery, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors. The recall is being conducted due to reports of alignment peg fractures in the instruments. The affected product is the 00-4309-029-00 Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile.
The recall includes all lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel, as all reported fractured instruments were made with this material. The source text indicates that units manufactured with 13-8 stainless steel are also part of the retrieval context, though the specific scope of the 13-8 steel units is cut off in the provided text. A total of 75 units are affected, with 51 located in the USA.
The products were distributed nationwide in the USA and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom. Affected lot numbers include 60444332, 60537066, 60549565, 60605852, 60612792, 60633381, 60708954, 60743404, 60773946, 60870480, 60915146, 60979391, and 61004027. Healthcare providers should stop using these instruments and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile 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 (13)
- Part 00-4309-029-00: Lot 60444332
- 60537066
- 60549565
- 60605852
- 60612792
- 60633381
- 60708954
- 60743404
- 60773946
- 60870480
- 60915146
- 60979391
- and 61004027.
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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