Recalls / —

—#138616

Product

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

FDA product code

HTZ — Instrument, Cutting, Orthopedic

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Serial numbers: 100067, 100076, 100371, 100372, 100063, 100065, 100069, 100076, and 100055; Foreign: Item number 530.710 Serial numbers: 100020, 100026, 100039, 100248, 100254, 100257, 100263, 100265, 100269, 100270, 100293, 100296, 100307, 100313, 100315, 100339, and 100340.

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

The Anspach Effort, Inc.

Address

4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235

Distribution

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.

Timeline

Recall initiated

2015-07-01

Posted by FDA

2015-08-05

Terminated

2016-12-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #138616. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.