Z-2608-2016 Class II Terminated
FDA device recall Z-2608-2016 was initiated by Richard Wolf Medical Instruments Corp. on May 19, 2016 and is designated Class II. Reason for recall: The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the… The recall status is terminated (terminated November 30, 2017). Affected quantity: Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2016
- Initiation Date
- May 19, 2016
- Termination Date
- November 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces
Product Description
Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
Reason for Recall
The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.
Distribution Pattern
U.S. Consignees: AK, AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, TX, UT and VA.
Code Information
Product number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922