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Class 2 Device Recall Synthes Resorbable Fixation Systems Resorbable Taps and Screws |
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| Date Initiated by Firm |
March 30, 2006 |
| Date Posted |
April 26, 2006 |
| Recall Status1 |
Terminated 3 on September 20, 2006 |
| Recall Number |
Z-0792-06 |
| Recall Event ID |
35109 |
| Product Classification |
Plate, Bone - Product Code JEY
|
| Product |
Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. |
| Code Information |
Product, Catalog #, Lot #, Expiration Date 1.5MM resorbable cortex screw 3MM-sterile, 800.603.10S, 1373642, 07/2009; 1.5MM resorbable cortex screw 3MM-sterile, 800.603.20S, 1372400, 07/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1384887, 08/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1393224, 09/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2162367, 10/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2175547, 01/2010; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2183488, 02/2010; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.10S, 1371226, 07/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.20S, 1371227, 07/2009; 1.5MM resorbable cortex screw 5MM-sterile, 800.605.10S, 1372687, 07/2009; 1.5MM resorbable cortex screw 6MM-sterile, 800.606.10S, 1373640, 07/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1384577, 08/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1387942, 09/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.10S, 1373751, 07/2009; 2.0MM resorbable cortex screw 4MM-sterile, 801.004.10S, 1374122, 07/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2162368, 10/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2184323, 02/2010; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.10S, 1374135, 07/2009; 2.5MM resorbable emergency screw 8MM-sterile, 801.048.02S, 1384578, 8/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1384602, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1393219, 09/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1372401, 07/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1376216, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1377498, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.20S, 1372402, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2169297, 12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2180984, 02/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384597, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384598, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384599, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1392087, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1392088, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1393230, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2162401, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163458, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163459, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2164282, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2167890, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2169299, 12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175554, 01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175801, 01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370038, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370040, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370041, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375932, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375933, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1376307, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1377501, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1377502, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1380682, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385761, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385763, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385764, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385780, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1388207, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1390841, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1392090, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1393233, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1393234, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1370039, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1376219, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1377503, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1378428, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1383881, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1390843, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1392089, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2167288, 11/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2181842, 02/2010; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 1384604, 08/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 1392091, 09/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 2167289, 11/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 1374134, 07/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 2175551, 01/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.02S, 1393239, 09/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.02S, 2181849, 02/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.04S, 2164288, 10/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 1373641, 07/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 2167291, 11/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile, 805.608.02S, 2171103, 12/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile, 805.608.04S, 2175552, 01/2010; 1.5MM rapid resorbable tack 4MM-sterile, 805.614.04S, 1387950, 09/2009; 1.5MM rapid resorbable tack 4MM-sterile, 805.614.10S, 2165696, 11/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160255, 09/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160256, 09/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1374125, 07/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1377504, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.02S, 2167290, 11/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1384596, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388815, 09/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1385773, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388795, 09/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.10S, 1374136, 07/2009; 2.5MM rapid resorbable emergency screw 4MM-sterile, 806.044.02S, 1392093, 09/2009; 2.5MM rapid resorbable emergency screw 6MM-sterile, 806.046.02S, 2163371, 10/2009. |
Recalling Firm/
Manufacturer |
Synthes (USA)
1302 Wrights Lane East
West Chester PA 19380
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| For Additional Information Contact |
R. Scott Eden
610-719-5862
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Manufacturer Reason
for Recall |
Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.
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FDA Determined
Cause 2 |
Other |
| Action |
Synthes Craniofacial Sales consultants were notified and instructed to immediately notify their accounts concerning this recall. Synthes contacted the customer accounts via phone 3/31/06 through 4/3/06 and subsequently via Certified Mail on 4/3/06. |
| Quantity in Commerce |
3511 |
| Distribution |
Nationwide and Canada. Distribution to 1 Military/Government account - Tripler Army Medical Center, Honolulu, HI; 1 foreign account - Synthes Canada; and geographical distribution within the United States to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, AND WV. |
| 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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