Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Produ
FDA device recall Z-2153-2017 · posted 2017-05-23 · Terminated
Recall details
- Recalling firm
- Innovasis, Inc
- Reason for recall
- Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
- Action taken
- Distributors are being notified by e-mail, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis on 5/5/17. Additional follow-up may be done via telephone and fax to return products.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 21
- Distribution
- US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
- Date initiated
- 2017-05-05
- Date posted
- 2017-05-23
- Date terminated
- 2017-08-01
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTERYX ANTERIOR CERVICAL PLATE SYSTEM (K061147) | Innovasis, Inc. | 2006-06-30 |