Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.

FDA device recall Z-2345-2015 · posted 2015-08-05 · Terminated

Recall details

Recalling firm

The Anspach Effort, Inc.

Reason for recall

Saw head separated from the drive unit or began to come loose.

Action taken

DePuy Synthes sent an " Urgent Notice Medical Device Recall (Removal) letter dated July 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTION REQUIRED: Our records show that your facility has the affected product(s) subject to this removal. The Anspach Effort, on behalf of DePuy Synthes asks that you review your inventory and immediately remove any affected BPLII Battery Oscillator devices from stock. In addition to this letter, your DePuy Synthes Sales Consultant has been provided with new product(s) to immediately replace the affected product(s). If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your DePuy Synthes Sales Consultant.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HTZ

Quantity affected

360 handpieces (Currently there are 9 affected units remaining in the US and 17 units OUS all others were reworked)

Distribution

Worldwide Distribution - US Distribution to the states of : AR, LA, OH, and WA., and the countries of : China, France, Italy, Russia, South Africa, Switzerland, and United Kingdom.

Date initiated

2015-07-01

Date posted

2015-08-05

Date terminated

2016-12-14

Location

Palm Beach Gardens, FL