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Class 3 Device Recall Look Brand Black Monofilament Nylon Suture |
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| Date Initiated by Firm |
September 24, 2005 |
| Date Posted |
October 21, 2005 |
| Recall Status1 |
Terminated 3 on December 14, 2005 |
| Recall Number |
Z-0085-06 |
| Recall Event ID |
33771 |
| Product Classification |
Suture, Nonabsorbable, Synthetic, Polyamide - Product Code GAR
|
| Product |
Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units. |
| Code Information |
Lot number M732780 |
Recalling Firm/
Manufacturer |
Surgical Specialties Corp
100 Dennis Dr
Reading PA 19606-3776
|
| For Additional Information Contact |
Dianna Shurr
610-404-1000 Ext. 2229
|
Manufacturer Reason
for Recall |
mislabeled as double armed straight needle actually single armed straight needle
|
FDA Determined
Cause 2 |
Other |
| Action |
On 9/24/05, the recalling firm issued notifications to their customers via fax informing them of the problem and the need to return any remaining product to the recalling firm. |
| Quantity in Commerce |
27 boxes |
| Distribution |
The product was shipped to hospitals in IL, KY, NC, NE, OR, UT, and VA. The product was also shipped to distributors in FL, KY, PA, TN, and VA. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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