CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report
Product 26 consists of all product under product recalled
Zimmer Manufacturing is recalling Product 26 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-1124-2016
- 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 26 consists of all product under product code: JWH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL 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 no.: 61555543 61597965 61670825 62079145 62079148 62124066 62135039 62185960 62203621 62221041 62221043 62221044 62267947 62267949 62267950 62268526 62277492 62277493 62278701 62278702 62278703 62340123 62397828 62397831 62267950N 62278701N 62278702N 62278703N 61597959 61653581 62218170 62265345 62277494 62294359 62218170N 62277494N 62294359N 61292730N 62122127 62267951 62267952 62278704 62267952N 62278704N 62181482 62304835 62304835N 62203622 62203622N 62289044 62391711 62289044N 62391711V 61854615 61977887 62135046 62162460 62267946 62268527 62340121 62268527N 62289054 62289083 62304837 62289054N 62289083N 62304837N
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 3,097| 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 |