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Class 2 Device Recall 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile |
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| Date Initiated by Firm |
July 26, 2017 |
| Create Date |
March 05, 2018 |
| Recall Status1 |
Terminated 3 on September 10, 2018 |
| Recall Number |
Z-0901-2018 |
| Recall Event ID |
79157 |
| Product Classification |
Reamer - Product Code HTO
|
| Product |
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S
Reaming Rods are intended for guiding of reamers during orthopedic surgery. |
| Code Information |
Distributed 21-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H229232 2/14/2017 2026-01-31 H239057 4/9/2017 2026-02-28 H333939 4/9/2017 2026-02-28 H333940 4/9/2017 2026-02-28 H294380 4/16/2017 2026-03-31 H294383 4/16/2017 2026-03-31 H339342 4/18/2017 2026-03-31 H339343 4/18/2017 2026-03-31 H339349 4/18/2017 2026-03-31 H340100 4/18/2017 2026-03-31 H340112 4/18/2017 2026-03-31 H340114 4/18/2017 2026-03-31 H294387 4/19/2017 2026-03-31 H294393 4/19/2017 2026-03-31 H341135 4/19/2017 2026-03-31 H342141 4/19/2017 2026-03-31 H294373 4/21/2017 2026-03-31 H340383 4/21/2017 2026-03-31 H340912 4/21/2017 2026-03-31 H341208 4/21/2017 2026-03-31 H342137 4/21/2017 2026-03-31 H341210 4/22/2017 2026-03-31 H343361 4/22/2017 2026-03-31 H343364 4/22/2017 2026-03-31 H343365 4/22/2017 2026-03-31 H297302 4/25/2017 2026-03-31 H340913 4/25/2017 2026-03-31 H341207 4/25/2017 2026-03-31 H341213 4/25/2017 2026-03-31 H342135 4/25/2017 2026-03-31 H342142 4/25/2017 2026-03-31 H297313 4/28/2017 2026-03-31 H297328 4/28/2017 2026-03-31 H341209 4/28/2017 2026-03-31 H341212 4/28/2017 2026-03-31 H342136 4/28/2017 2026-03-31 H342140 4/28/2017 2026-03-31 H297312 5/3/2017 2026-03-31 H297324 5/3/2017 2026-03-31 H297330 5/3/2017 2026-03-31 H297336 5/3/2017 2026-03-31 H297333 5/4/2017 2026-03-31 H297337 5/4/2017 2026-03-31 H297350 5/4/2017 2026-03-31 H297358 5/4/2017 2026-03-31 H340918 5/4/2017 2026-03-31 H341132 5/4/2017 2026-03-31 H297329 5/6/2017 2026-03-31 H297360 5/6/2017 2026-03-31 H297366 5/6/2017 2026-03-31 H297356 5/10/2017 2026-03-31 H297359 5/10/2017 2026-03-31 H297362 5/10/2017 2026-03-31 H297374 5/10/2017 2026-03-31 H294394 5/11/2017 2026-04-30 H294401 5/11/2017 2026-04-30 H297319 5/11/2017 2026-04-30 H297340 5/11/2017 2026-04-30 H297383 5/11/2017 2026-04-30 H325599 5/11/2017 2026-04-30 H340394 5/11/2017 2026-04-30 H294404 5/12/2017 2026-04-30 H294407 5/12/2017 2026-04-30 H297307 5/12/2017 2026-04-30 H297308 5/12/2017 2026-04-30 H297310 5/12/2017 2026-04-30 H297334 5/12/2017 2026-04-30 H297343 5/12/2017 2026-04-30 H297370 5/12/2017 2026-04-30 H297377 5/12/2017 2026-04-30 H297380 5/12/2017 2026-04-30 H297385 5/12/2017 2026-04-30 H335085 5/12/2017 2026-04-30 H294391 5/18/2017 2026-04-30 H297309 5/18/2017 2026-04-30 H335089 5/18/2017 2026-04-30 H342583 5/18/2017 2026-04-30 H297315 5/23/2017 2026-04-30 H297367 5/23/2017 2026-04-30 H297386 5/23/2017 2026-04-30 H325607 5/23/2017 2026-04-30 H325615 5/23/2017 2026-04-30 H294402 5/24/2017 2026-04-30 H297335 5/24/2017 2026-04-30 H325600 5/24/2017 2026-04-30 |
Recalling Firm/
Manufacturer |
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
|
| For Additional Information Contact |
Anne Brisson
610-719-5443
|
Manufacturer Reason
for Recall |
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
|
FDA Determined
Cause 2 |
Process control |
| Action |
The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 7/26/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following:
If you DO have any of the identified devices and intend to re-sterilize the product (TRAUMA Products only) per the package insert, please take the following steps:
¿ Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located and will be re-sterilized. Also, please indicate the number of devices found. Please include your name, title, telephone number and signature in the spaces provided.
¿ Send a copy of the completed Verification Section to Synthes by:
o Fax: 844-721-3045 or
o Scan/email: Synthes5735@stericycle.com
Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification.
If you DO have any of the identified devices, and are returning the product for replacement, please take the following steps:
¿ Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number.
¿ Complete the Verification Section (page 4 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return
¿ Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided.
¿ Return the Verification Section (page 4 of this letter) with the product to:
o Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.
¿ Send a copy of the completed Verification Section to Synthes by:
o Fax: 844-721-3045 or
o Scan/email: Synthes5735@stericycle.com
Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clea |
| Quantity in Commerce |
6257 |
| Distribution |
Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada. |
| 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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