The Recall Desk
HighFDA (Devices)·Z-2215-2012·Announced 2012-08-22

Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors Due to Fractures

Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures. The recall affects units manufactured from 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 structural defect (fractures) in a surgical instrument. Per the rubric, risk-of-harm products where injury has not yet been reported (only instrument fractures are mentioned) fall under the High severity category.

Plain-English summary

Zimmer, Inc. is recalling specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors due to reports of alignment peg fractures. The recall specifically targets 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 not part of this specific retrieval.

The affected product is identified by part number 00-4309-029-01. The recall covers 212 units, with 179 distributed in the United States and the remainder distributed internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom. Specific lot numbers affected include 60535162, 60545338, 60576488, 60605855, 60637022, 60689253, 60772974, 60875277, 60918060, 60989817, 61011689, 61024161, and 61051024.

Healthcare providers and facilities should check their inventory for these specific part numbers and lot numbers. If the product is found, it should be removed from use and returned to Zimmer, Inc. per the recall instructions. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

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. Th
Manufacturer
Zimmer, Inc.
Category
Medical Device — Surgical Instrument
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 00-4309-029-01: Lot 60535162
  • 60545338
  • 60576488
  • 60605855
  • 60637022
  • 60689253
  • 60772974
  • 60875277
  • 60918060
  • 60989817
  • 61011689
  • 61024161
  • and 61051024.

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.

See all 4 products in this recall →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · instrument fracture

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