CLASS II Device recall · Reported 19 Dec 2018 · FDA Enforcement Report
Orthopedic Salvage System (OSS) Porous Stem recalled by Zimmer Biomet
Zimmer Biomet is recalling Orthopedic Salvage System (OSS) Porous Stem, distributed in Indiana, Maryland, Missouri, Mississippi, New Mexico. The recall was initiated on 10 Oct 2018 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-0590-2019
- FDA event ID
- 81528
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2018
- FDA classified
- 7 Dec 2018
- Reported
- 19 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 10 Oct 2018 | Recall initiated by company | |
| 7 Dec 2018 | Classified by FDA | +58 days |
| 19 Dec 2018 | Published in enforcement report | +12 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 is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
Product as listed by the FDA
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Where it was distributed
Distributed to accounts in IN, MD, MO, MS, and NM.
Questions about this recall
Why was it recalled?
Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
Which lots are affected?
068390
Where was it sold?
Distributed to accounts in IN, MD, MO, MS, and NM.
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
1 other product · FDA event 81528| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Comprehensive Mini Stem recalled by Zimmer Biomet | Zimmer Biomet | Other | 5 states |
More recalls from Zimmer Biomet
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|---|---|---|---|---|---|
| Device | CLASS II | Spinal Rod Cutter recalled by Zimmer Biomet | Zimmer Biomet | Other | Nationwide |
| Device | CLASS II | Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal recalled | Zimmer Biomet | Device Malfunction | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D. recalled | Zimmer Biomet | Other | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Other | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Other | 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 |