CLASS II Device recall · Reported 12 Dec 2018 · FDA Enforcement Report
Biomet Compress Device Short Anchor Plug With Drill Set recalled
Zimmer Biomet is recalling Biomet Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant, distributed nationwide in the US. The recall was initiated on 24 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-0553-2019
- FDA event ID
- 81513
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Oct 2018
- FDA classified
- 4 Dec 2018
- Reported
- 12 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 24 Oct 2018 | Recall initiated by company | |
| 4 Dec 2018 | Classified by FDA | +41 days |
| 12 Dec 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma. The Compress¿ Segmental Femoral Replacement System (Short Spindle and Anchor Plug) components are intended for uncemented use only.
Where it was distributed
US Nationwide Distribution in the states of IN, DC, MD
Questions about this recall
Is Biomet Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant recalled?
Yes. Zimmer Biomet recalled Biomet Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant on 24 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0553-2019.
Why was it recalled?
Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
Which lots are affected?
Lot Number: 608740 UDI Number: (01)00880304461666(17)271113(10)608740
Where was it sold?
US Nationwide Distribution in the states of IN, DC, MD
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.
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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 |