CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report
Product 12 consists of all product under product recalled
Zimmer Manufacturing is recalling Product 12 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-1110-2016
- 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 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36 902603610 6 DEGREE COCR FEM HEAD 36 902603614 6 DEGREE COCR FEM HEAD 36 Product Usage: For use in total or hemi hip 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 no62240860 62339639 62395853 62240859 62279765 62339640 62395852 62089508 62094969 62185962 62240862 62273366 62279766 61660149 62279769 62284368 62284368N 62284371 62093453
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 |