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Terminated

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

FDA Recall Z-2345-2015 · Posted 2015-08-05

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHTZ
Date Initiated2015-07-01
Date Terminated2016-12-14
Product Quantity360 handpieces (Currently there are 9 affected units remaining in the US and 17 units OUS all others were reworked)

Reason for Recall

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

Firm Action

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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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