Device Recall Synthes

Part Number  05.001.012  Lot Numbers AV18166 AV19044 AV20666

Orthopedic Devices

1

No

Nationwide Distribution

Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.

Part numbers:03.010.048 and 03.010.052 with  Lot Numbers:  4874015 4874021 4927262 4954481 4963192 4874016 4874022 4944750 4957586 4963193 4784017 4899564 4944751 4957587 4972003 4874018 4899565 4954478 4957588 4972004 4874019 4927260 4954479 4957589  4874020 4927261 4954480 4963190  4922533 4922975 4981158  4922970 4923015 4981159  4922971 4977241 4981160  4922972 4977242 4981162  4922973 4981156 5035905  4922974 4981157 5035906

General and Plastic Surgery Devices

1

No

Nationwide Distribution

Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). || The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.

Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026,  9124016, 9124027, 8918563

Orthopedic Devices

2

Yes

US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA

Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

Part Number: 359.219,  Sold As Lot Numbers: 4321659 4340451 4466686 4470900 5496455 5700078 5718485 5718486 5718487 1904339 3005674 3005675 3009312 3020674 3025607 3051190 3054608 3065013 3069566 3084637 3098634 3121438 3232931 3242304 3262712 3301017 3325276 3382583 3410330 3430483 3493588 3504996 3524633 3619119 3626055 3659645 3706611 3797835 7505411 7565990 7601112 7619995 7670741 7675623 7727696 7774491 7810649 7845943 7874224 7896075 7979727 4796463 4826021 4911859 4911860 4969014 4971314 5066417 5042001 5066418 5090226 5090224 5106335 5123586 5162204 5123587 5162205 5162206 5162760 5181760 5181761 5227459 5236654 5258103 5420946 5422955 5455364 5455365 5507788 5525235 5485078 5492810 5545372 5555604 5569028 5611445 5611446 5611447 5641430 5670475 5641429 5657075 5657073 5670474 5700077 5700079 8114862 8214803 8326267 8424513 8476286 8541845 8608192 8608193 8768253 8973607 9275702 4389269 4537554 4594280 4594281 4825384;  (Manufacturing Lot Numbers: 1095607 1095607 1121876 1121876 1641700 1806500 1811056 1811059 1813900 1904339 3005674 3005675 3009312 3020674 3025607 3051190 3054608 3065013 3069566 3084637 3098634 3121438 3232931 3242304 3262712 3301017 3325276 3382583 3410330 3430483 3493588 3504996 3524633 3619119 3626055 3659645 3706611 3797835 7505411 7565990 7601112 7619995 7670741 7675623 7727696 7774491 7810649 7845943 7874224 7896075 7979727 8000136 8002518 8002635 8002635 8004538 8004538 8005179 8006103 8006214 8006214 8006578 8006578 8007139 8007139 8007472 8007472 8008046 8008046 8008046 8008261 8009205 8009363 8009859 8012109 8012353 8012925 8013244 8014078 8014078 8014645 8014645 8015605 8015831 8016063 8016128 8016128 8016128 8016423 8016423 8016759 8017447 8017590 8017862 8017872 8018319 8114862 8214803 8326267 8424513 8476286 8541845 8608192 8608193 8768253 8973607 9275702 A8LA901 A8MA648 A8MB744 A8NA025 A8NA430)

Orthopedic Devices

1

No

Nationwide Distribution

Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. || This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.

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Orthopedic Devices

1

No

Worldwide Distribution - US (nationwide including DC, Hawaii, and Puerto Rico) and Internationally to Argentina, Austria, Australia, Belgium, Bahrain, Bolivia, Brazil, Canada, China, Chile, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Great Britain, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Lebanon, Sri Lanka, Libyan Arab Jamahiriya, Morocco, Macedonia, Mexico, Malaysia, Netherlands, Norway, Nepal, New Zealand, Oman, Ontario, Peru, Philippines, Palestine, Portugal, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, South Africa, El Salvador, Thailand, Turkey, Taiwan, Ukraine, Uruguay, Venezuela, Vietnam and United Arab Emirates.

Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.