CLASS II Device recall · Reported 20 Mar 2019 · FDA Enforcement Report
NexGenTrabecular Metal Tibial Half Block Augment recalled
Zimmer Trabecular Metal Technology is recalling NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4, distributed nationwide in the US. The recall was initiated on 1 Feb 2019 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-1006-2019
- FDA event ID
- 82125
- Recalling firm
- Zimmer Trabecular Metal Technology, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Feb 2019
- FDA classified
- 11 Mar 2019
- Reported
- 20 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 1 Feb 2019 | Recall initiated by company | |
| 11 Mar 2019 | Classified by FDA | +38 days |
| 20 Mar 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potentially comingled, resulting in the product in the box potentially not matching the product on the label
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
NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.
Where it was distributed
Worldwide Distribution - US Nationwide Distribution in the states of AL, CA, CO, ID, MS,NE, NJ, NY, OH, OR, PA, TX, VA, WI and Foreign CANADA, JAPAN, GERMANY , NETHERLANDS
Nationwide AlabamaCaliforniaColoradoIdahoMississippiNebraskaNew JerseyNew YorkOhioOregonPennsylvaniaTexasVirginiaWisconsin
Questions about this recall
Why was it recalled?
Potentially comingled, resulting in the product in the box potentially not matching the product on the label
Which lots are affected?
Lot Numbers: 63244259 63247617 63279968 61581585T (01) 00889024307902 (17) 210131 (10) 63244259 (01) 00889024307902 (17) 210228 (10) 63247617 (01) 00889024307902 (17) 210228 (10) 63279968 (01) 00889024307902 (17) 210228 (10) 61581585T
Where was it sold?
Worldwide Distribution - US Nationwide Distribution in the states of AL, CA, CO, ID, MS,NE, NJ, NY, OH, OR, PA, TX, VA, WI and Foreign CANADA, JAPAN, GERMANY , NETHERLANDS
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 82125| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | NexGenTrabecular Metal Tibial Half Block Augment recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
More recalls from Zimmer Trabecular Metal Technology
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NexGenTrabecular Metal Tibial Half Block Augment recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
| Device | CLASS III | The TM Ardis Interbody System implant is a convex recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
| Device | CLASS II | Porous Patella - 00587806532 Porous Patella recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
| Device | CLASS II | 00720504022 Acetab.cupw/sh,0deg,22mmx40mm recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
| Device | CLASS II | Rev. Shell Liner 0d 00700504828 Rev. Shell Liner 10d recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |