The Anspach Effort, Inc. '***REF SIL-3-10***1.93 mm Suture Pass Drill/ 1.17 eye. Use with B-SILVER Attachment.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" Lot number: B113005418. Product Usage: Cutting and shaping Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
'***REF SIL-3-10***1.93 mm Suture Pass Drill/ 1.17 eye. Use with B-SILVER Attachment.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" Lot number: B113005418. Product Usage: Cutting and shaping
Brand
The Anspach Effort, Inc.
Lot Codes / Batch Numbers
Lot number: B113005418.
Products Sold
Lot number: B113005418.
The Anspach Effort, Inc. is recalling '***REF SIL-3-10***1.93 mm Suture Pass Drill/ 1.17 eye. Use with B-SILVER Attachment.***ANSPACH***St due to The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
Recommended Action
Per FDA guidance
The firm, Anspach sent an "URGENT PRODUCT REMOVAL" letter on May 29, 2008, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for all products listed on the attached "Product Replacement Form." Upon visual inspection if the pouch is sealed on both ends it is sterile. If one end of the pouch is not sealed it is non-sterile and should be returned for credit or replacement. 2) Complete the "Product Replacement Form" by indicating the quantity returned, and whether the customer would prefer to have their returned devices replaced, or their account credited. 3) Place products to be returned in a box and mark the box with the Return Authorization Number on the "Product Replacement Form." 4) Use the Anspach FedEx account number listed on the form to return the unused devices with the completed "Product Replacement Form." Following receipt of the form, Anspach will process the request immediately. For questions related to the product replacement, please contact Customer Service at 800-327-6887. For questions related to the Voluntary Removal, please contact Anspach Regulatory Affairs and Quality Assurance at 800-327-6887.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026