Z-1678-2016Class II
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN...
Zimmer Manufacturing B.V. / initiated 2016-05-04 / Terminated / root cause: packaging
Zimmer Manufacturing B.V. began a recall of M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical... on . FDA classified it as Class II and gives the reason as "A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1678-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer Manufacturing B.V.
- Product
- M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
- Product code
- HSB Rod, Fixation, Intramedullary And Accessories
- Reason for recall
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Root cause tag
- packaging
- FDA root cause
- Packaging change control
- Action
- All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
- Quantity in commerce
- 219
- Distribution
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- Product codes and lots
- LOTS: 63295051 63293672
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1673-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1674-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1675-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1676-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1677-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1678-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1679-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1680-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1681-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1682-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1683-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1684-2016 | Class II | Terminated | Voluntary: Firm initiated |
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