Z-0993-2018Class II
Juggerknot 2.9Mm 2 #2 Mb
Zimmer GmbH / initiated 2017-06-30 / Terminated / root cause: packaging
Zimmer Biomet, Inc. began a recall of JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty on . FDA classified it as Class II and gives the reason as "For soft tissue fixation". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0993-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
- Product code
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Reason for recall
- For soft tissue fixation
- Root cause tag
- packaging
- FDA root cause
- Packaging process control
- Action
- On June 2, 2017 an URGENT Medical Recall Letter was issued to customers regarding affected product(s). The letter requests customers to review the content and notify affected personnel of the recall. Assist the sales representative in quarantining affected product, which will be removed and returned to recalling firm and then replaced. All customers who may have received product from distributors are to be notified. Questions or concerns can be directed to 1-574-372-4847.
- Quantity in commerce
- 50
- Distribution
- US in the state of Texas
- Product codes and lots
- Part number: 912050 Lot number: 221890
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0992-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0993-2018 | Class II | Terminated | Voluntary: Firm initiated |
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