CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report
Product 48 consists of all product under product recalled
Zimmer Manufacturing is recalling Product 48 consists of all product under, distributed nationwide in the US. The recall was initiated on 11 Jan 2016 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-1146-2016
- FDA event ID
- 72900
- Recalling firm
- Zimmer Manufacturing, Mercedita, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2016
- FDA classified
- 12 Mar 2016
- Reported
- 23 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 11 Jan 2016 | Recall initiated by company | |
| 12 Mar 2016 | Classified by FDA | +61 days |
| 23 Mar 2016 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, for use in total knee arthroplasty
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Which lots are affected?
lot no.: 61873094 61895696 61905916 61905918 61905920 61919766 61919767 61919768 61956249 61956250 61981202 61981204 61999375 62027331 62060784 62074467 62074469 62096750 62096751 62133740 62164984 62168517 62171693 62171694 62171696 62174936 62205101 62213332 62213333 62220943 62345691 62345692 62345693 62345694 62352447 62352450
Where was it sold?
US Nationwide Distribution
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
70 other products · FDA event 72900This product is part of a recall event; the main page for the event is Product 25 consists of all product under product recalled.
More recalls from Zimmer Manufacturing
All 90| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Periarticular plating system, cancellous bone screw recalled | Zimmer Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Mini MagnaFx Cannulated Screw Fixation System Small recalled | Zimmer Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled | Zimmer Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Herbert Cannulated Bone Screw System, Bone Screw Dia recalled | Zimmer Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled | Zimmer Manufacturing | Sterility | Nationwide |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |