CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report
Segmental fluted stem, 17x250mm bwd, Sterile recalled by Zimmer Biomet
Zimmer Biomet is recalling Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer, distributed nationwide in the US. The recall was initiated on 28 Feb 2017 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-2573-2017
- FDA event ID
- 76629
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Feb 2017
- FDA classified
- 14 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 28 Feb 2017 | Recall initiated by company | |
| 14 Jun 2017 | Classified by FDA | +106 days |
| 21 Jun 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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
Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Where it was distributed
Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand
Questions about this recall
Is Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer recalled?
Yes. Zimmer Biomet recalled Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer on 28 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-2573-2017.
Why was it recalled?
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Which lots are affected?
Item Number: 00585205417, Lot Number Expiry Date Before: September 2026
Where was it sold?
Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand
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 21 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 Biomet
All 873| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Spinal Rod Cutter recalled by Zimmer Biomet | Zimmer Biomet | Sterility | Nationwide |
| Device | CLASS II | Polaris 5 Spinal System and Polaris 5/Cypher Spinal System recalled | Zimmer Biomet | Device Malfunction | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D. recalled | Zimmer Biomet | Sterility | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Sterility | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | 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 | Nitrosamine Impurity | 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) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |