CLASS II Device recall · Reported 1 Apr 2015 · FDA Enforcement Report
NexGen Trabecular Metal Femoral Augment Block Distal Only recalled
Zimmer Trabecular Metal Technology is recalling NexGen Trabecular Metal Femoral Augment Block Distal Only Augment, Size D, Sterile, distributed in California. The recall was initiated on 4 Feb 2015 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-1325-2015
- FDA event ID
- 70605
- Recalling firm
- Zimmer Trabecular Metal Technology, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Feb 2015
- FDA classified
- 26 Mar 2015
- Reported
- 1 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 4 Feb 2015 | Recall initiated by company | |
| 26 Mar 2015 | Classified by FDA | +50 days |
| 1 Apr 2015 | 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
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
Product as listed by the FDA
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: 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 Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.
Where it was distributed
US Distribution in the state of CA
Questions about this recall
Why was it recalled?
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
Which lots are affected?
20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T
Where was it sold?
US Distribution in the state of CA
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.
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 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 |
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 |