Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to pro
FDA device recall Z-0938-2013 · posted 2013-03-11 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
- Action taken
- The firm initiated a recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter, dated January 11, 2013, to all consignees. The letter identified the affected product and the issue, as well as requested that consignees examine their inventory for the product(s) with the identified Part and Lot Numbers, remove them from use, and return them to Synthes. Customers were to follow the steps provided in the letter regarding if they had or did not have any of the identified affected product. Questions were to be directed to 610-719-5450 or Fieldaction@synthes.com.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MNH
- Quantity affected
- 18
- Distribution
- Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.
- Date initiated
- 2013-01-11
- Date posted
- 2013-03-11
- Date terminated
- 2015-09-10
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLICK'X (K992739) | Synthes Spine | 2000-02-08 |