CLASS II Device recall · Reported 22 Aug 2012 · FDA Enforcement Report
00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner recalled
Zimmer is recalling 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 65¿ Neck Angle Per surgical, distributed nationwide in the US. The recall was initiated on 18 Jul 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2213-2012
- FDA event ID
- 62540
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2012
- FDA classified
- 16 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 18 Jul 2012 | Recall initiated by company | |
| 16 Aug 2012 | Classified by FDA | +29 days |
| 22 Aug 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet."
Where it was distributed
Worldwide Distribution - USA (nationwide) and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.
Questions about this recall
Is 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 65¿ Neck Angle Per surgical recalled?
Yes. Zimmer recalled 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 65¿ Neck Angle Per surgical on 18 Jul 2012. The recall is Class II and its status is Terminated. Recall number Z-2213-2012.
Why was it recalled?
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
Which lots are affected?
Part 00-4309-028-01: Lot 60529860, 60574377, 60589079, 60605856, 60616574, 60684774, 60842967, 60739623, 60896979, 60936815, 61019785, 61051017
Where was it sold?
Worldwide Distribution - USA (nationwide) and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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